Comparison of ketorolac tromethamine 0.5% and loteprednol etabonate 0.5% for inflammation after phacoemulsification: prospective randomized double-masked study.

PURPOSE: To compare the efficacy of a topical nonsteroidal antiinflammatory agent (ketorolac tromethamine ophthalmic solution 0.5%) and a topical steroid (loteprednol etabonate ophthalmic suspension 0.5%) in controlling inflammation after cataract surgery. SETTING: Magill Research Center for Vision Correction, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: Sixty patients were prospectively and randomly assigned to receive topical treatment with ketorolac tromethamine ophthalmic solution 0.5% or loteprednol etabonate ophthalmic suspension 0.5% starting the day after routine phacoemulsification for cataract extraction. Both patient and investigator were masked to treatment. All patients had uneventful small-incision phacoemulsification with placement of a foldable posterior chamber intraocular lens (IOL). Patients used 1 of the 2 antiinflammatory agents 4 times a day starting 24 hours after surgery. Signs and symptoms of inflammation as documented by external slitlamp examination, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated on postoperative days 1, 4, 7, and 30. RESULTS: There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements or in IOP between groups. No patient in either group was removed from the study for lack of treatment efficiency. CONCLUSIONS: Ketorolac tromethamine ophthalmic solution 0.5% was as effective as loteprednol etabonate ophthalmic suspension 0.5% in reducing inflammation after routine phacoemulsification and IOL implantation. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.     

Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery

PURPOSE: To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation. DESIGN: Multicenter clinical study. PARTICIPANTS: One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group. METHODS: Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled. MAIN OUTCOME MEASURES: The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity. RESULTS: Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells (P: = 0.002) and flare (P: = 0.009), conjunctival erythema (P: = 0.010), ciliary flush (P: = 0.022), photophobia (P: = 0.027), and pain (P: = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P: = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. CONCLUSIONS: Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.     

Comparison of ketorolac tromethamine 0.5% and rimexolone 1% to control inflammation after cataract extraction. Prospective randomized double-masked study

PURPOSE: To compare the efficacy of a topical nonsteroidal anti-inflammatory agent (ketorolac tromethamine 0.5%) with that of a topical steroid (rimexolone 1%) to control inflammation after cataract surgery. SETTING: Storm Eye Institute, Department of Ophthalmology, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: Thirty-six patients were prospectively and randomly assigned to receive topical treatment with either ketorolac tromethamine 0.5% or rimexolone 1% starting the day after routine cataract extraction. Treatment was masked to both patient and investigator. Each patient had uneventful small incision phacoemulsification with placement of a foldable posterior chamber intraocular lens. Patients used 1 of the 2 antiinflammatory agents 4 times each day starting 24 hours after surgery. No antiinflammatory medications were used preoperatively, intraoperatively, or for 24 hours postoperatively. Signs and symptoms of inflammation, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated 1, 4, 7, and 30 days postoperatively. RESULTS: There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements. In addition, there was no difference in IOP measurements between groups. CONCLUSIONS: Ketorolac tromethamine 0.5% was as effective as rimexolone 1% in reducing inflammation after cataract surgery. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.     

Efficacy of preoperative versus postoperative ketorolac tromethamine 0.5% in reducing inflammation after cataract surgery

PURPOSE: To compare the efficacy of 30 minute preoperative versus 1 day postoperative administration of ketorolac tromethamine 0.5% ophthalmic solution (Acular) in reducing anterior chamber inflammation after cataract surgery. SETTING: The Hermann Eye Center, The University of Texas Health Science Center-Houston, Texas, USA. METHODS: Fifty eyes of 48 consecutive patients scheduled for phacoemulsification with intraocular lens implantation were included. Before surgery, patients were randomly assigned to start the study drug 30 minutes preoperatively or 1 day postoperatively. No other antiinflammatory agents were used intraoperatively or postoperatively. Main outcome measures were flare and cell counts. RESULTS: Preoperative and postoperative flare and cell counts did not differ significantly between the 2 treatment groups at any time. Both groups showed significant increases in flare (P =.0001) and cells (P =.0001) 1 day postoperatively. Flare and cells returned to baseline levels by day 28 in both groups. There was no significant difference at any time between the 2 groups in the change from the preoperative level of inflammation. CONCLUSIONS: There was no difference between administering ketorolac 30 minutes preoperatively versus 1 day postoperatively in reducing inflammation.     

Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial

PURPOSE: To investigate the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution (Acular; Allergan, Inc, Irvine, California) in the treatment of moderate to severe anterior segment inflammation developing after unilateral cataract surgery with intraocular lens implantation. METHODS: Only patients who exhibited moderate or greater levels of cells and flare 1 day after surgery were included in this multicenter, double-masked, randomly assigned, parallel-group study. Topical ketorolac or vehicle solution (Allergan, Inc) was administered to the treated eye four times daily, starting the day after surgery and continuing for 14 days. RESULTS: Ketorolac was significantly more effective than the vehicle solution in reducing anterior chamber cells (P < or = .030) and flare (P < or = .025), conjunctival erythema (P < or = .046), ciliary flush (P < or = .006), tearing (P < or = .012), photophobia (P < or = .014), and pain (P < or = .049). Half as many patients from the ketorolac group (14/51) were discontinued from the study for lack of efficacy, compared with the vehicle group (28/51; P = .005). There was no significant difference between ketorolac and the vehicle solution in changes in visual acuity, intraocular pressure, biomicroscopic or ophthalmoscopic variables, or adverse events. CONCLUSIONS: Ketorolac tromethamine 0.5% ophthalmic solution is safe and provides substantial anti-inflammatory activity in the treatment of moderate to severe anterior segment inflammation developing after cataract surgery and intraocular lens implantation.     

Comparison of prednisolone 1%, rimexolone 1% and ketorolac tromethamine 0.5% after cataract extraction

Purpose To compare the efficacy, safety and patient comfort of two topical steroids (prednisolone 1% and rimexolone 1%) and a topical non-steroidal anti-inflammatory agent (ketorolac tromethamine 0.5%) after extracapsular cataract extraction.Methods Forty-five patients were enrolled in this prospective, randomized, double-blind study. They were assigned to receive topical treatment with either prednisolone, rimexolone or ketorolac tromethamine ophthalmic solution after phacoemulsification for cataract extraction. On postoperative days 1, 3, 5, 14 and 28 best-corrected visual acuity, intraocular pressure (IOP), slit-lamp examination of the anterior segment and report of the patients comfort were assessed and compared by Friedman rank time analysis.Results Regarding the primary outcome efficacy of inflammation control the assessment of cells did not differ (p=0.165), while flare in the anterior chamber was lowest (p=0.008) in the non-steroidal anti-inflammatory drug (NSAID) group. Surface inflammation was lowest with prednisolone (p=0.002). Regarding safety, visual acuity did not differ among the groups. In the prednisolone group one patient, however, responded to steroid treatment with elevated IOP and had to be excluded. In the remaining patients IOP was even lower in the two steroidal treatment groups than with ketorolac (p=0.030). One patient receiving ketorolac had to be excluded because a corneal erosion developed. Patient comfort was highest with prednisolone (p=0.041).Conclusions Ketorolac tromethamine provides good control of intraocular inflammation after cataract extraction without the risk of a steroidal IOP increase, which was also not observed under rimexolone therapy. The best surface inflammation control and patient comfort was observed with prednisolone, which remains a good choice.The authors have no proprietary interest in any of the equipment or materials used in this study.     

Comparison of the efficacy and safety of ketorolac tromethamine 0.5% and prednisolone acetate 1% after cataract surgery.

PURPOSE: To compare the anti-inflammatory and analgesic efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with those of prednisolone acetate 1% in patients having cataract surgery. SETTING: Shawnee Mission Eye Care, Shawnee Mission, Kansas, USA. METHODS: This double-blind, randomized, single-site study comprised 59 healthy men and women with a clinical diagnosis of routine ocular cataract requiring surgical removal. All patients had extracapsular cataract extraction and posterior chamber intraocular lens implantation. After surgery, patients were randomized to receive ketorolac tromethamine 0.5% or prednisolone acetate 1%, self-instilled in the treated eye, according to the following schedule: 1 to 2 drops 4 times daily (week 1); 3 times daily (week 2); 2 times daily (week 3); once daily (week 4). Patients were examined postoperatively on days 1, 7, and 28. Intraocular anti-inflammatory efficacy was assessed by lid edema, lid injection, conjunctival injection, corneal edema, ciliary flush, and anterior chamber cells. Analgesic efficacy was assessed by patient self-rated pain severity, pain frequency, total symptom sum, and overall global improvement. RESULTS: Both treatments produced comparable reductions in intraocular inflammation and pain after cataract surgery and were well tolerated by patients. No adverse events were reported, and there were no significant changes in intraocular pressure in either group. Improvements in visual acuity were also similar in both groups. CONCLUSION: Ketorolac tromethamine 0.5% ophthalmic solution was as effective and well-tolerated as prednisolone acetate 1% solution in controlling postoperative inflammation and pain after cataract surgery.     

Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients

PURPOSE: To evaluate the safety and analgesic efficacy of ketorolac tromethamine 0.4% ophthalmic solution in postoperative photorefractive keratectomy (PRK) patients. SETTING: Fifteen clinical sites in the eastern and southern United States. METHODS: This pooled analysis of 2 multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies comprised 313 patients having unilateral PRK. After surgery, patients were treated with 1 drop of ketorolac tromethamine 0.4% ophthalmic solution (Acular(R) LS) (n = 156) or vehicle (n = 157) 4 times daily for up to 4 days. Pain intensity, pain relief, use of escape medication, and severity of ocular symptoms were assessed. Adverse events, epithelial healing, and visual acuity were recorded. RESULTS: There was significantly less pain intensity experienced by patients in the ketorolac group (P<.001). During the first 12 hours post PRK, 50% fewer patients in the ketorolac group than in the vehicle group had severe to intolerable pain (41.6% [64/154] and 84.5% [131/155], respectively). The median time to no pain was 30 hours in the ketorolac group and 54 hours in the vehicle group (P<.001, survival analysis). Ketorolac patients reported significantly greater pain relief than vehicle patients throughout the study (P<.001). Ketorolac patients used significantly less escape medication than vehicle patients for 48 hours post PRK (P< or =.008). Treatment-related adverse events occurred in 2.6% (4/156) of ketorolac patients and 6.4% (10/157) of vehicle patients. CONCLUSION: Ketorolac 0.4% ophthalmic solution is safe and effective in reducing ocular pain when used 4 times daily for up to 4 days post PRK.     

The effect of ketorolac tromethamine solution 0.5% in reducing postoperative inflammation after cataract extraction and intraocular lens implantation

Ketorolac tromethamine solution 0.5% (1 drop 3 times daily) was more effective than the placebo vehicle solution in suppressing postoperative anterior ocular inflammation after extracapsular cataract extraction (ECCE) and intraocular lens (IOL) implantation in this multicenter, double-masked, randomized study. Four of 60 ketorolac-treated patients compared with 25 of 58 placebo-treated patients required supplemental corticosteroid therapy to suppress inflammation in the postoperative period which was statistically significant (P less than 0.001). Even though these supplemental steroid-treated patients were kept in the analysis, the placebo-treated group showed more evidence of anterior ocular inflammation as measured by anterior segment fluorophotometry. This was consistent with slit-lamp observations of increased anterior ocular inflammation. This study supported previous studies that suggested ketorolac tromethamine ophthalmic solution 0.5% was effective and safe as a nonsteroidal anti-inflammatory agent for topical use after ECCE and IOL implantation.     

Effectiveness and tolerance of piroxicam 0.5% and diclofenac sodium 0.1% in controlling inflammation after cataract surgery

PURPOSE: To compare the efficacy and tolerance of piroxicam 0.5% ophthalmic solution and diclofenac sodium 0.1% ophthalmic solution in controlling inflammation after phacoemulsification and intraocular lens (IOL) implantation. SETTING: Ophthalmological Department, San Donà di Piave Hospital, Venice, Italy. MATERIALS AND METHODS: Forty consecutive patients--18 men and 22 women--between 55 and 85 years of age (mean age, 75.1 +/- 7.12 years) who were scheduled for cataract extraction with phacoemulsification and IOL implantation were randomized to receive 0.5% piroxicam ophthalmic solution (piroxicam group, 20 patients) or 0.1% diclofenac sodium ophthalmic solution (diclofenac group, 20 patients) for 1 month postoperatively. Best-corrected visual acuity (BCVA) and intraocular pressure (IOP) measurements and slit-lamp biomicroscopy for the evaluation of corneal edema, Descemet membrane folds, Tyndall, and cells in the anterior chamber were carried out in all patients 1 day, 4 days, and 1 month postoperatively. Subjective symptoms after the nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution instillation were assessed using a questionnaire. RESULTS: There were no significant differences between the two groups in postoperative IOP, BCVA, anterior chamber flare and cell levels, corneal edema, or Descemet membrane folds. Ocular discomfort, evaluated as burning or stinging sensation after NSAID ophthalmic solution instillation, was significantly more frequent and intense in the diclofenac-treated eyes. Two eyes in the diclofenac group had a mild transient punctate keratitis. CONCLUSIONS: These results suggest that piroxicam is as effective as diclofenac sodium in preventing inflammation after cataract surgery with IOL implantation, and its better tolerance and safety can provide higher patient compliance.     

Treatment of acute pseudophakic cystoid macular edema: Diclofenac versus ketorolac

PURPOSE: To investigate whether topical diclofenac sodium 0.1% solution (Voltaren Ophthalmic) is as efficacious as topical ketorolac tromethamine 0.5% solution (Acular) in the treatment of established, chronic cystoid macular edema (CME) after uneventful phacoemulsification cataract extraction with posterior chamber intraocular lens (IOL) implantation. SETTING: Referral-based vitreoretinal private practice. METHODS: This randomized prospective study comprised 34 consecutive patients with clinical CME after uneventful phacoemulsification cataract extraction with posterior chamber IOL implantation who were referred to a private vitreoretinal practice for evaluation and management. Exclusion criteria included a history of previous intraocular surgery, vitreous loss during cataract surgery, CME, uveitis, and vitreoretinal pathology. The eye with CME was treated with 1 drop 4 times daily of diclofenac sodium 0.1% solution or ketorolac tromethamine 0.5% solution. Outcomes were measured by observing for improvement in CME and visual acuity. RESULTS: Both treatment methods resulted in a significant reduction in CME and a significant improvement in visual acuity. Within 26 weeks, diclofenac reduced CME in 16 patients (89%) and ketorolac, in 14 patients (88%) (P =.92, confidence interval [CI] 95%). Within 26 weeks, diclofenac eliminated CME in 14 patients (78%) and ketorolac, in 12 patients (75%) (P =.86, CI 95%). The mean time to initial CME reduction was 7.5 weeks with diclofenac and 8.0 weeks with ketorolac (P =.41, CI 95%). The mean time to CME resolution was 13.6 weeks with diclofenac and 12.8 weeks with ketorolac (P =.49, CI 95%). CONCLUSIONS: Diclofenac sodium 0.1% solution and ketorolac tromethamine 0.5% topical ophthalmic solution eyedrops were equally effective in reducing the severity and duration of CME after uneventful phacoemulsification with posterior chamber IOL implantation. Either solution may be considered for CME after cataract surgery, especially in patients who may not tolerate corticosteroid treatment.     

Preoperative ketorolac tromethamine 0.4% in phacoemulsification outcomes: pharmacokinetic-response curve

PURPOSE: To assess the clinical benefit, relative efficacy, and pharmacokinetic-response curve of preoperative and postoperative ketorolac tromethamine 0.4% (Acular LS) to improve outcomes during and after cataract surgery. SETTING: Private clinical practice. METHODS: One hundred patients were randomized in a double-masked fashion to 4 groups of 25 to receive ketorolac for 3 days, 1 day, or 1 hour or a placebo before phacoemulsification. All treatment groups received ketorolac 0.4% for 3 weeks postoperatively; the placebo group received vehicle. Outcomes measures were preservation of preoperative mydriasis, phacoemulsification time and energy, operative time, corneal clarity, endothelial cell counts, postoperative inflammation, intraoperative and postoperative discomfort, complications, and incidence of clinically significant cystoid macular edema (CME). RESULTS: Maintenance of pupil size with 3-day ketorolac dosing was significantly better than with 1-day dosing (P<.01), which was significantly better than with 1-hour or placebo dosing (P<.01). Both 3-day and 1-day dosing were superior to 1-hour or placebo dosing. No patient receiving ketorolac 0.4% for 1 or 3 days developed CME compared with 12% of patients in the control (placebo) group and 4% in the 1-hour group. Three-day and 1-day dosing of ketorolac reduced surgical time, phacoemulsification time and energy, and endothelial cell loss and improved visual acuity in the immediate postoperative period compared with 1-hour predosing and the placebo (P<.05). CONCLUSION: The preoperative use of ketorolac tromethamine 0.4% for 3 days followed by 1-day of predosing provided optimum efficacy and superior outcomes relative to 1-hour pretreatment and a placebo.     

Topical ketorolac tromethamine 0.5% versus diclofenac sodium 0.1% to inhibit miosis during cataract surgery

PURPOSE: To compare the effect of topical ketorolac tromethamine 0.5% solution and topical diclofenac sodium 0.1% solution on the inhibition of surgically induced miosis. SETTING: Tertiary care teaching hospital in South India. METHODS: Fifty-one patients were prospectively randomized to receive ketorolac 0.5% or diclofenac 0.1% at 3 intervals preoperatively. Patients with diabetes mellitus, pseudoexfoliation, or local pupil abnormalities were excluded from the study. Mydriatics comprising homatropine 1% plus phenylephrine 10% were instilled in all patients 1 hour before the peribulbar block at 5 intervals. Horizontal pupil diameters were obtained at the beginning of surgery, after capsulotomy, after intraocular lens (IOL) implantation, and at the end of surgery. RESULTS: The mean horizontal pupil diameter was 7.40 mm at the start of surgery in both groups. The ketorolac group showed a consistent trend toward larger pupil diameters at subsequent surgical intervals. Changes from baseline also indicated more significant inhibition of miosis in the ketorolac group. CONCLUSIONS: Topical ketorolac was a more effective inhibitor of miosis than topical diclofenac during extracapsular cataract extraction and IOL implantation. It also provided a more stable mydriatic effect throughout surgery.     

Effectiveness of ketorolac tromethamine 0.5% ophthalmic solution for chronic aphakic and pseudophakic cystoid macular edema

The effect of ketorolac tromethamine 0.5% ophthalmic solution (a new nonsteroidal anti-inflammatory agent) treatment was compared to placebo treatment in patients with chronic, angiographically proven aphakic or pseudophakic cystoid macular edema (visual acuity less than or equal to 20/40 for six months) during a three- to four-month double-masked, randomized study. Twenty-six patients completed this study without significant ocular or systemic toxicity. The improved distance visual acuity observed in the ketorolac treatment group (8/13 patients) was statistically different from the improved vision observed in the placebo treated group (1/13 patients) (P = .005). No patient on a regimen of ketorolac therapy had a significant decrease in Snellen distance visual acuity while on treatment, but two patients in the placebo group demonstrated a decrease in visual acuity of two lines or more. Fluorescein angiography was consistent with changes in visual acuity.     

The effect of ketorolac tromethamine in reducing postoperative inflammation: double-mask parallel comparison with dexamethasone

Anterior chamber fluorophotometry was done after the oral administration of fluorescein sodium in patients undergoing extracapsular cataract extraction and posterior chamber intraocular lens insertion before and after surgery. The administration of ketorolac solution 0.5% eye drops before and after surgery decreased the breakdown of the blood-aqueous barrier as much as did dexamethasone sodium phosphate solution 0.1% (dexamethasone solution) eye drops at each postoperative time period as measured by fluorophotometry. Slit-lamp observations of postoperative anterior ocular inflammation were not different between treatment groups. Both ketorolac and dexamethasone solutions were well tolerated by patients. No additional corticosteroids were given to any patients during the study. Therefore, ketorolac solution was as effective as dexamethasone solution in suppressing postoperative inflammation after cataract surgery as measured by fluorophotometry and as observed by slit-lamp examinations. This study confirms prior studies that suggest ketorolac ophthalmic solution 0.5% may be effective and safe as a nonsteroidal antiinflammatory agent for topical use after cataract surgery and intraocular lens implantation and as a substitute for topically applied corticosteroids.     

Efficacy and Safety of Rimexolone 1% Versus Prednisolone Acetate 1% in the Control of Postoperative Inflammation Following Phacoemulsification Cataract Surgery

PURPOSE: The aim of this study was to evaluate the efficacy and safety of rimexolone 1% ophthalmic suspension compared to that of 1% prednisolone acetate in the control of inflammation in eyes undergoing cataract extraction with phacoemulsification followed by posterior chamber intraocular lens implantation. METHODS: Forty-eight patients who underwent uncomplicated cataract extraction with phacoemulsification followed by posterior chamber IOL implantation constituted the study group of this prospective, randomized, double-masked investigation. Patients were randomly assigned to two treatment groups; rimexolone 1% ophthalmic suspension (27 subjects) or prednisolone acetate 1% (21 subjects). Postoperatively, patients used topical rimexolone or prednisolone drops four times a day for 15 days. Patients were examined at the first postoperative day (day 1), and days 3, 7 and 15. The major efficacy parameters assessed clinically on each visit were anterior chamber cells, anterior chamber flare and conjunctival hyperemia. Safety of the rimexolone was evaluated by IOP values and the presence of adverse effects. RESULTS: Regarding all three efficacy parameters, rimexolone was found to be clinically and statistically equivalent to prednisolone acetate. Intraocular pressure values during the postoperative period were also similar in both groups. CONCLUSION: Rimexolone 1% ophthalmic suspension is both an effective and safe topical steroid in controlling postoperative inflammation after cataract extraction with phacoemulsification.     

The safety of intraocular ketorolac in rabbits

PURPOSE: To assess the safety of a possible substitute treatment for intraocular steroid injections, intraocular injections of ketorolac tromethamine, one of the nonsteroidal anti-inflammatory drugs, were performed in rabbits. METHODS: Either 0.5% or 0.25% preservative-free ketorolac tromethamine ophthalmic solution (0.1 mL) was injected into the vitreous of the right eye of 15 rabbits. Physiologic saline solution (BSS; Alcon, Ft. Worth, TX) was injected into the left eye of each rabbit as a control. A standard electroretinogram and intraocular pressure measurements were obtained before injection, and repeated 1 day and 1, 2, 3, and 4 weeks after injection. After 4 weeks, the rabbits were euthanatized and the retinas examined by light and electron microscopy. Differences in the electroretinograms, intraocular pressure, and histopathology between the two eyes were recorded. Further, the elimination half-life of the drug in the vitreous was assessed. RESULTS: There were no statistically significant differences in electroretinograms, or intraocular pressure measurements obtained between the ketorolac-injected eyes and the control eyes. The half life of the drug was measured to be 2.3 hours. No histopathologic changes were observed in study eyes compared with control eyes. CONCLUSIONS: Preservative-free ketorolac tromethamine is nontoxic to the retinas of rabbits when injected intravitreally and could be considered as an alternative to intraocular steroid injections.     

A comparison of morning and evening instillation of a combination travoprost 0.004%/timolol 0.5% ophthalmic solution

PURPOSE: To compare the intraocular pressure lowering efficacy and side effect profile of travoprost 0.004%/timolol 0.5% ophthalmic solution dosed in the morning and evening. METHODS: This was a multicenter, prospective, randomized, double-masked, parallel group clinical study of 92 patients with open-angle glaucoma (with or without pseudoexfoliative or pigmentary glaucoma) or ocular hypertension. After a washout of existing glaucoma medications, patients were randomly assigned to receive one drop of travoprost 0.004%/timolol 0.5% in the morning or evening for 6 weeks. The main outcome measures were mean intraocular pressure (IOP) assessed at 9 am, 11 am, and 4 pm, and safety variables. RESULTS: Travoprost 0.004%/timolol 0.5% ophthalmic solution, dosed in the morning or evening, controlled IOP consistently throughout the day. Mean IOP ranged from 16.5 to 16.7 mmHg in the morning treatment group and from 16.1 to 17.2 mmHg in the evening treatment group. Travoprost 0.004%/timolol 0.5% ophthalmic solution produced statistically significant and clinically relevant reductions in IOP from baseline; mean reductions ranged from approximately 8 to 10 mmHg (32% to 38%). Travoprost 0.004%/timolol 0.5% ophthalmic solution was safe and well tolerated with the most frequently reported adverse event being ocular hyperemia, which occurred in 12.5% of patients in the morning treatment group and 13.6% of patients in the evening treatment group. CONCLUSIONS: Travoprost 0.004%/timolol 0.5% given once daily, either in the morning or evening, is a safe and effective treatment for open-angle glaucoma and ocular hypertension. It may be beneficial for patients judged to be inadequately controlled on a prostaglandin analogue or ophthalmic beta-blocker alone.     

Pain reduction after laser in situ keratomileusis with ketorolac tromethamine ophthalmic solution 0.5%: a randomized, double-masked, placebo-controlled trial

PURPOSE: To evaluate the analgesic efficacy of ketorolac tromethamine ophthalmic solution 0.5% after laser in situ keratomileusis (LASIK). METHODS: In this two-center, randomized, double-masked, placebo-controlled, parallel group study, 39 patients underwent bilateral simultaneous LASIK. Patients received study drops (Acular PF or Lens Plus) in both eyes 15 to 30 minutes before surgery, again immediately before passing of the microkeratome, and again after flap repositioning. Proparacaine was used during surgery, but no additional therapeutics were used for the next 24 hours, except acetaminophen or propoxyphene napsylate acetaminophen allowed as escape medication. Patients rated their eye pain hourly through 6 hours after surgery. RESULTS: Ketorolac significantly reduced eye pain at every time point compared to placebo (P<.01). Escape medication use declined significantly; 16% (3/19) of those who received ketorolac required escape medication compared to 50% (8/16) of placebo-treated patients (P=.03). Ketorolac-treated eyes were pain-free significantly sooner (P<.01), with 47% (18/38) having pain cessation by hour 4, compared to 15% (5/33) of placebo-treated eyes. No treatment-related adverse events occurred. CONCLUSION: This study supports the use of topical ketorolac for control of early postoperative pain following LASIK, significantly increasing patient comfort and reducing usage of other pain medications.     

Rimexolone 1% versus prednisolone acetate in preventing early postoperative inflammation after cataract surgery

Purpose: To compare the efficacy and safety of rimexolone 1% and prednisolone acetate 1% ophthalmic suspensions in controlling intraocular inflammation in the early period after cataract surgery. Methods: Eighty patients undergoing cataract extraction with intraocular lens implantation, either planned extra capsular cataract extraction (PECCE) or phacoemulsification surgery, were evaluated in a prospective, randomized, observer-masked, clinical trial in which efficacy in controlling early postoperative inflammation and safety of prednisolone acetate 1% one eye drop every 4 h (n = 36 eyes) was compared with that of rimexolone 1% one eye drop every 4 h (n = 44 eyes) in an eighteen day course. Efficacy was assessed from changes of the anterior chamber cell count, flare, conjunctival hyperemia, and ciliary congestion by means of slit lamp biomicroscopy on days 1, 3, 8, 15, and 18. Intraocular pressure (IOP) and possible side effects were also recorded on each visit. Results: Anterior chamber cell count and flare showed no difference in the two groups at any visits. The rimexolone group was associated with significantly higher score for conjunctival hyperemia on days one and three (P < 0.05) and the prednisolone acetate group was associated with a significantly higher score for corneal edema on day 8 (P < 0,05). However, there were no between group differences in IOP. Conclusions: Rimexolone 1% ophthalmic suspension was as effective and safe as prednisolone acetate 1% ophthalmic suspension in controlling inflammation in the early period after cataract surgery.