Penetration of betaxolol HCL ionic suspension 0.25% and betaxolol HCL solution 0.50% into the aqueous humor

PURPOSE: To determine the intraocular penetration of topical drops of betaxolol HCl 0.25% suspension and betaxolol HCl 0.50% solution into the aqueous humor. METHODS: Fifteen patients were randomly assigned to receive topical betaxolol HCl 0.25% suspension (n=7) or topical betaxolol HCl 0.50% solution (n=8) the day before cataract surgery. Aqueous samples were collected 2 hours after the administration of the morning dose during cataract surgery. Drug concentrations were determined by high-performance liquid chromatography with fluorescence detection. RESULTS: The mean aqueous humor concentration of topical betaxolol HCl 0.25% suspension was 275.1+/-168.8 micro g/mL (range 570-70 micro g/mL) and the mean aqueous humor concentration of topical betaxolol HCl 0.50% solution was 195.4+/-102.4 micro g/mL (range 334-50 micro g/mL) (p=0.281). CONCLUSIONS: The mean aqueous humor concentration of betaxolol 0.25% suspension was higher than betaxolol 0.50% solution; however, the difference was not statistically significant. With twofold reduced concentration and similar anterior chamber penetration, betaxolol 0.25% suspension could be first choice for Beta 1 selective blocker therapy when considered for patients with glaucoma.     

A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension

PURPOSE: The primary objective of this study was to compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination to the concomitant administration of travoprost 0.004% (TRAVATAN) and timolol 0.5% in subjects with open angle glaucoma or ocular hypertension. METHODS: This was a randomized, multicenter, double-masked, active-controlled, parallel group study. Three hundred sixteen patients with open angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.004%/timolol 0.5% ophthalmic solution fixed combination once daily in the morning or concomitant administration of timolol 0.5% once daily in the morning and travoprost 0.004% ophthalmic solution once daily in the evening. The efficacy and safety of the fixed combination were compared with concomitant therapy over three months. The primary efficacy outcome measure was mean intraocular pressure. RESULTS: Both travoprost 0.004%/timolol 0.5% fixed combination and the concomitant administration of travoprost 0.004% and timolol 0.5% produced statistically significant reductions from baseline in IOP, with mean IOP ranging from 15.2 to 16.5 mm Hg in the patients using travoprost 0.004%/timolol 0.5% fixed combination compared with 14.7 to 16.1 mm Hg in the concomitant group. The upper 95.1% confidence limit for the differences in mean IOP (fixed combination minus concomitant) was < or =1.5 mm Hg at 7 of 9 visits, including all three 8 AM time points, 24-hours post-dose. Mean IOP reductions from baseline ranged from 7.4 to 9.4 mm Hg in the fixed combination group compared with 8.4 to 9.4 mm Hg with concomitant therapy. Safety analysis demonstrated equivalent safety between the two treatment groups. CONCLUSIONS: A fixed combination of travoprost 0.004% and timolol 0.5% produced clinically relevant IOP reductions in patients with open angle glaucoma or ocular hypertension that were comparable to concomitant therapy with its components. Safety and tolerability of the fixed combination were also equivalent to concomitant therapy. Travoprost 0.004%/timolol 0.5% fixed combination offers IOP reduction equivalent to concomitant therapy, with potential benefits that include convenience (fewer bottles and drops per day), improved compliance, cost savings (based on fewer co-payments), and elimination of potential washout effects.     

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.     

A comparison of therapeutic regimens containing moxifloxacin 0.5% ophthalmic solution and gatifloxacin 0.3% ophthalmic solution for surgical prophylaxis in patients undergoing LASIK or LASEK.

The purpose of these two studies was to compare the safety and tolerability of moxifloxacin 0.5% ophthalmic solution and gatifloxacin 0.3% ophthalmic solution for use with laser-assisted in situ keratomileusis (LASIK) and laser-assisted subepithelial keratomileusis (LASEK) patients. Treatment with the two antibiotic regimens was randomly assigned to fellow eyes of each patient. The LASIK study showed no difference between the two therapies in terms of visual acuity, pupil size, SPK, edema, haze, day- and nighttime glare, halos, clarity of day or night vision, and dry eye symptoms up to 1 week after surgery. Patients reported no preference between the two antibiotics on the basis of ease of use, irritation, redness, itching, gritty, sandy or scratchy feeling, speed of recovery, overall vision, or overall comfort up to 7 days after LASIK surgery. Corneal healing after LASEK surgery was equivalent for the antibiotic regimens containing moxifloxacin 0.5% ophthalmic solution and gatifloxacin 0.3% ophthalmic solution. When comparing safety and tolerability, these findings suggest an equivalent role for these fluoroquinolone antibiotics in surgical prophylaxis.     

Comparison of lodoxamide 0.1% ophthalmic solution and levocabastine 0.05% ophthalmic suspension in vernal keratoconjunctivitis.

PURPOSE: To compare the clinical efficacy and safety of lodoxamide 0.1% ophthalmic solution with levocabastine 0.05% ophthalmic suspension, each given four times daily (QID) for three months to patients with vernal keratoconjunctivitis (VKC). METHODS: The study was conducted multinationally according to a triple-masked parallel design in 95 VKC patients, with assessments at baseline then monthly during the three months of treatment. The primary efficacy variables were a Physician's Clinical Judgement Scale and a Patient's Overall Judgement Scale of improvements from baseline. Signs and symptoms of VKC were also assessed. RESULTS: Both primary efficacy variables showed significantly greater overall improvement of VKC from baseline with lodoxamide than levocabastine. The superiority of lodoxamide was demonstrated by the Physician's Clinical Judgement Scale at months 2 and 3, with a trend, at month 1, and by the Patient's Overall Judgement Scale at months 1, 2 and 3. All signs and symptoms of VKC improved significantly from baseline at all time points, regardless of treatment (p<0.001). However, relative to levocabastine, conjunctival discharge, photophobia and lacrimation were significantly reduced by lodoxamide at months 1, 2 and 3, itching at months 2 and 3, and bulbar conjunctiva at month 3. The temporal improvement of superior tarsal papillae did not differ significantly between treatments. Both were well tolerated. CONCLUSIONS: Lodoxamide 0.1% and levocabastine 0.05% eye drops, instilled four times daily for three months, were effective, safe and well tolerated by patients with VKC, but lodoxamide was significantly superior to levocabastine.     

A randomized, double-masked, placebo-controlled, multicenter comparison of loteprednol etabonate ophthalmic suspension, 0.5%, and placebo for treatment of keratoconjunctivitis sicca in patients with delayed tear clearance

PURPOSE: To evaluate loteprednol etabonate ophthalmic 0.5% suspension, versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance. DESIGN: Randomized, double-masked, placebo-controlled clinical trial. METHODS: Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were randomly assigned to receive either loteprednol or vehicle 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued. Symptoms were scored using a visual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulbar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 to 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms. RESULTS: In subsets of patients with at least moderate clinical inflammation, there was a significant difference between the loteprednol-treated group and vehicle-treated group after 2 weeks of therapy. The differences did not reach statistical significance at 4 weeks, although the loteprednol-treated patients retained their improvement compared with the vehicle-treated group. Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported. CONCLUSION: The use of topical loteprednol etabonate 0.5% 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component.     

A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis

OBJECTIVE: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (QUIXIN) with 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. DESIGN: Prospective, randomized, active-controlled, double-masked, multicenter study. PARTICIPANTS: Four hundred twenty-three patients with a clinical diagnosis of bacterial conjunctivitis were enrolled. METHODS: Patients were randomly assigned to receive either 0.5% levofloxacin (n = 211) or 0.3% ofloxacin (n = 212) for 5 days (every 2 hours on days 1 and 2 and every 4 hours on days 3-5). Conjunctival cultures were obtained, and ocular signs and symptoms were evaluated on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). End point was defined as the last evaluable observation. MAIN OUTCOME MEASURES: Primary microbial and clinical outcomes were based on culture results and resolution of cardinal signs, respectively. Secondary efficacy assessments included evaluations of ocular signs and symptoms. RESULTS: Two hundred eight patients (levofloxacin, n = 109; ofloxacin, n = 99) were evaluated for efficacy. Microbial eradication rates were significantly greater in the 0.5% levofloxacin treatment group compared with the 0.3% ofloxacin group at both the final visit (89% vs. 80%, P = 0.034) and at end point (90% vs. 81%; P = 0.038). Treatment with 0.5% levofloxacin was significantly more effective in resolving photophobia than was 0.3% ofloxacin treatment (94% vs. 73%, P = 0.006). Both study medications were well tolerated, with a low incidence of adverse events. CONCLUSIONS: Although clinical cure rates in the 0.5% levofloxacin and 0.3% ofloxacin treatment groups were similar, a 5-day treatment regimen with 0.5% levofloxacin achieved microbial eradication rates that were statistically superior to those attained with 0.3% ofloxacin. Despite the higher concentration of active drug in 0.5% levofloxacin versus 0.3% ofloxacin, there was no difference between treatment groups in the incidence of treatment-related adverse events.     

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.     

Evaluation of 0.4% ketorolac tromethamine ophthalmic solution versus 0.5% ketorolac tromethamine ophthalmic solution after phacoemulsification and intraocular lens implantation.

PURPOSE: The aim of this study was to compare the effectiveness and patient tolerance of 0.4% ketorolac tromethamine ophthalmic solution and 0.5% ketorolac tromethamine ophthalmic solution after routine phacoemulsification and lens implantation. Setting: The setting for this study was the Storm Eye Institute and Magill Research Center for Vision Correction, Medical University of South Carolina (Charleston, SC). METHODS: This work was a prospective, double-masked study that included 40 eyes of 40 patients randomly assigned to receive topical treatment with 0.4% ketorolac or 0.5% ketorolac, starting 15 min prior to routine phacoemulsification and foldable posterior chamber intraocular lens implantation. Following the procedure, patients were instructed to use the assigned treatment agent 4 times a day after surgery for 1 week and twice a day for 3 weeks, when drops were discontinued. Slit-lamp examination, intraocular pressure (IOP), laser cell and flare measurements, and subjective patient tolerance were evaluated postoperatively at 1, 7, and 30 d. Comparisons between the 2 groups were made at each visit, as well as comparisons to baseline. A P=value less than .05 was considered statistically significant. RESULTS: At day 1, a higher percentage of patients (70% vs. 40%) reported symptoms (mainly foreign body sensation and stinging/burning) in the 0.5% ketorolac group, compared to the 0.4% ketorolac group. No significant differences were found between the 2 groups over time regarding best-corrected visual acuity (BCVA), IOP, slit-lamp assessment of cells, and cell and flare measured using the laser cell/flare meter. CONCLUSIONS: Treatment with 0.4% ketorolac tromethamine ophthalmic solution is as effective as 0.5% ketorolac tromethamine ophthalmic solution in reducing inflammation after routine cataract surgery. Patients reported less discomfort using 0.4% ketorolac.     

A double-masked comparison of betaxolol vs timolol in the treatment of open-angle glaucoma

We conducted a six-month prospective, double-masked randomized trial comparing betaxolol with timolol at 0.25% and 0.5% concentrations in the treatment of primary open-angle glaucoma in 38 patients. To qualify, patients had to demonstrate an average intraocular pressure in at least one eye of greater than or equal to 26 mm Hg without treatment. The median intraocular pressure was consistently lower in the timolol group than in the betaxolol group (after four weeks of therapy, it was 20.2 mm Hg for timolol vs 22.5 mm Hg for betaxolol; P less than .04). Adjunctive therapy was required in eight patients in the betaxolol group compared to one in the timolol group (P less than .05). Betaxolol appears to be a clinically effective and safe agent in the treatment of open-angle glaucoma. However, the magnitude of the decrease in intraocular pressure with it may not be as great as that with timolol and there may be a greater need for adjunctive therapy with it than with timolol.     

A comparison of the ocular hypotensive efficacy of twice-daily 0.25% levobunolol to 0.5% timolol in patients previously treated with 0.5% timolol

Treatment with noncardioselective beta-adrenoceptor antagonists (e.g., 0.5% timolol or 0.5% levobunolol) is standard practice for lowering elevated intraocular pressure (IOP). However, because there are risks and side effects associated with the use of these agents, a lower, yet still effective, dose may be preferred. We gave 0.5% timolol twice daily for 30 days to 143 patients. In a double-masked, randomized fashion, we then assigned patients to continue to receive 0.5% timolol twice daily or 0.25% levobunolol twice daily for 8 weeks. The mean unmedicated baseline IOP for both groups was approximately 25 mm Hg. After 30 days of timolol pretreatment, the mean IOP in both groups decreased to approximately 19 mm Hg (p = 0.210). After the 30-day timolol pretreatment period, and subsequent randomization to either 0.5% timolol or 0.25% levobunolol treatment, there was little change in overall mean IOP (0.03 mm Hg decrease for levobunolol, 0.06 mm Hg increase for timolol; p = 0.811) from the timolol pretreatment baseline. One patient assigned to the timolol treatment group was terminated from the study due to inadequate control of IOP. We conclude that the mean IOP lowering effect of 0.25% levobunolol is equivalent to 0.5% timolol, and switching patients from twice-daily 0.5% timolol to twice-daily 0.25% levobunolol poses no significant risk of decreased ocular hypotensive efficacy.     

The safety and efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution

PURPOSE: To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Randomized multicenter, double-masked, active-controlled, parallel group study. METHODS: Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. RESULTS: Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P < or = .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P < or = .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. CONCLUSIONS: Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.     

Future of ophthalmic anti-infective therapy and the role of moxifloxacin ophthalmic solution 0.5% (VIGAMOX)

The vintage antibiotics that were available in the 1950s-1980s were sometimes toxic, had limited spectra, and were bacteriostatic agents, and they have been replaced by significantly broader-spectrum therapies. We ask more of our future antibiotic products for ophthalmology: they must be 1) broad spectrum, 2) convenient to use, 3) useful prophylactically, 4) effective therapeutically, 5) benzalkonium chloride-free, 6) comfortable, and 7) nontoxic. The emergence of antibiotic resistance has focused us on more potent agents effective against resistant strains of bacteria. Fluoroquinolones have become a dominant family of ophthalmic antibiotics. But even the older fluoroquinolones (e.g., ofloxacin, ciprofloxacin) have lost much of their effectiveness against some important ocular isolates. Considering all of the characteristics for an ideal ophthalmic antibiotic product available today, moxifloxacin ophthalmic solution 0.5% represents a primary antibiotic product of choice for treating and preventing ophthalmic infections.     

Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis. Emadine Study Group

PURPOSE: To determine the efficacy and tolerance of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects. METHODS AND MATERIALS: In a randomized, double-masked, parallel controlled study, emedastine 0.05% ophthalmic solution BID was compared to levocabastine 0.05% ophthalmic suspension BID, for control of the signs and symptoms of allergic conjunctivitis in pediatric subjects ages 3-16. Subjects who met all inclusion and exclusion criteria received masked study medication with instructions to instill drops twice daily, in the morning and evening. A diary was completed by the parents four times daily for the first two and last two weeks of the study. Treatment lasted 42 days. Drug efficacy was assessed at the initial administration in the office at Day 0 and after 3, 7, 14, 30 and 42 days. RESULTS: Overall results showed both drugs have an effect and that emedastine was significantly superior (p < 0.05) to levocabastine for the relief of chemosis on Days 14, 30 and 42; of itching on follow-up Days 30 and 42 (p < 0.05); of redness on Days 30 and 42; for eyelid swelling on Days 14 and 30; and for physician's impression score on Days 7, 14, 30 and 42. CONCLUSION: These results confirm previous preclinical and clinical data on the potent and long acting efficacy of this promising new ophthalmic anti-allergic drug, emedastine in pediatric subjects.     

A comparison of the efficacy and tolerability of 0.5% timolol maleate ophthalmic gel-forming solution QD and 0.5% levobunolol hydrochloride BID in patients with ocular hypertension or open-angle glaucoma.

The purpose of this study was to compare the ocular hypotensive efficacy and tolerability of 0.5% timolol maleate ophthalmic gel-forming solution (timolol gel) and 0.5% levobunolol hydrochloride (levobunolol). This was a randomized, double-masked, multi-center, active-controlled, 2-period, crossover study. After a 3-week, single-masked placebo run-in phase, patients with ocular hypertension or open-angle glaucoma and an intraocular pressure (IOP) > or = 22 mmHg were randomized to receive timolol gel QD or levobunolol BID for 6 weeks followed by a 3-week, placebo washout period. Patients were then crossed over to the alternate treatment for 6 weeks. IOP and heart rate (HR) were measured at 3 and 6 weeks after the start of therapy with either timolol gel or levobunolol. Of 133 patients randomized, 116 received both treatments. Timolol gel QD was comparable to levobunolol BID in reducing trough and peak IOP. At trough, HR was marginally increased with timolol gel and was decreased with levobunolol (p = < 0.001). At peak, HR was decreased with both treatments, but the decrease was significantly less with timolol gel than with levobunolol (p = 0.049). Significantly more patients experienced at least one adverse event (p = 0.024), adverse events related to special senses (p = 0.002), and burning and stinging (p < 0.001) with levobunolol compared to timolol gel. The study demonstrates that timolol gel QD has IOP-lowering effects comparable to those of levobunolol BID with fewer adverse experiences and less effect on HR.     

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.     

Safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution in cataract surgery patients

PURPOSE: To determine the safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution (Vigamox) in patients having cataract surgery. SETTING: American Eye Center, Manila, Philippines. METHODS: Preoperative and 1-month postoperative anterior chamber reaction, corneal endothelial cell density, and corneal thickness were assessed in 65 eyes that had cataract surgery with intracameral moxifloxacin. All eyes received 0.1 mL intracameral moxifloxacin 0.5% ophthalmic solution containing 500 mug of moxifloxacin as the last step of phacoemulsification. Different ophthalmologists conducted the postoperative evaluation in an observer-masked fashion. A P value less than 0.05 was considered significant. RESULTS: All 65 eyes completed the study. The mean age was 69.5 years +/- 9.13 (SD) (range 48 to 84 years). All eyes had a postoperative best corrected visual acuity of 20/30 or better. All eyes had trace to +2 cells and flare anterior chamber reaction only on the first day after surgery. The mean endothelial cell count was 2491.52 cells/mm(2) preoperatively and 2421.58 cells/mm(2) postoperatively. The mean difference was 70 cells/mm(2), which not statistically significant (P = .737). The increase of 17.80 microm in postoperative pachymetry 1 month after surgery was not statistically significant (P>.65). CONCLUSION: Intracameral Vigamox 0.5 mg/mL appeared to be nontoxic in terms of visual rehabilitation, anterior chamber reaction, pachymetry, and corneal endothelial cell density.