The relationship between habitual patient-reported symptoms and clinical signs among patients with dry eye of varying severity

PURPOSE: To investigate symptom profiles and clinical signs in subjects with dry eye and normal subjects in a cross-sectional multicenter study. METHODS: Subjects aged 35 to 65 were recruited according to dry eye diagnostic codes and telephone interview and completed the Dry Eye Questionnaire 2001, among others, and underwent dry eye clinical tests. RESULTS: Subjects (122) included 28 control subjects (C), 73 with non-Sj?gren's keratoconjunctivitis sicca (non-SS KCS) and 21 with Sj?gren's syndrome (SS). Subjects with SS or non-SS KCS reported discomfort and dryness most frequently and that many symptoms worsened over the day and were quite bothersome. Groups were significantly different in corneal fluorescein staining, conjunctival lissamine green staining, Schirmer 1 tear test, and tear break-up time (TBUT; chi2 and Kruskal-Wallis, P<0.0001). Statistically significant, but moderate, correlations were found between the frequency and evening intensity of dryness and discomfort and TBUT, Schirmer's tear test, overall corneal fluorescein staining, and temporal lissamine green conjunctival staining (Spearman r=0.31-0.45, P<0.01). Symptoms were moderately to highly correlated with the clinician's global grading of severity and highly correlated to patient's self-assessment of severity (r=0.46-0.86, P<0.0001), whereas signs showed lower correlations (r=0.22-0.46, P<0.0001). CONCLUSIONS: Subjects with SS or non-SS KCS reported frequent and intense ocular surface symptoms in the evening, some of which correlated moderately with clinical test results. The global clinician grade of dry eye correlated more highly with patient symptoms than did clinical signs, suggesting that patient symptoms influence dry eye diagnosis and grading of dry eye more than clinical test results.     

Controlled study of the use of autologous serum in dry eye patients.

PURPOSE: To determine the efficacy and safety of topical autologous serum as a treatment of dry eye patients. METHODS: A 2-month, prospective, single-masked, placebo-controlled study was conducted in patients with bilateral severe dry eye. One eye was randomized to receive the patient's own serum as a tear substitute, and the fellow eye received unpreserved normal saline solution as a placebo. Subjective symptoms and clinical parameters of dry eye including conjunctival impression cytology were assessed at baseline and 1 week, 1 month, and 2 months after treatment. RESULTS: Twelve dry eye patients were enrolled. Both subjective symptoms (discomfort, foreign-body sensation, dryness, and photophobia), objective signs (fluorescein and rose bengal staining and conjunctival impression cytology) improved significantly in treated eyes compared with baseline. Control eyes also had improvement in symptoms, signs, and rose bengal staining compared with baseline. Neither Schirmer test results nor tear break-up time improved in either group. The means score of all parameters were improved in both groups, and the results of conjunctival impression cytology were better in treated eyes; however, these results are not significantly different. There were no serious adverse effects observed in this study. CONCLUSIONS: There was a trend toward improvement in symptoms and signs of dry eye including cytologic changes after application of autologous serum in severe dry eye patients. However, this trend was not statistically significant. A larger scale study is warranted.     

Evaluation of topical cromolyn sodium in the treatment of vernal keratoconjunctivitis

A randomized, double-masked, placebo-controlled multicenter study was conducted for 6 weeks in 12 centers to evaluate the efficacy and safety of cromolyn sodium 4% ophthalmic solution (Opticrom) for the treatment of active bilateral vernal conjunctivitis. Objective clinical signs were graded weekly by an ophthalmologist while patients kept a daily record of the severity of their symptoms. Sixty-five patients completed the study; 35 received cromolyn sodium and 30 were treated with a matching placebo (the drug vehicle). Statistically significant differences in favor of cromolyn sodium treatment were found for conjunctival injection, limbal injection, limbal edema, tearing, and symptoms summary score. There were few side effects (usually mild stinging and burning which did not require drug stoppage). Only one patient required drug discontinuation for possible drug- or vehicle-related side effects. Cromolyn sodium was found to be significantly more effective than placebo in treating the signs and symptoms of vernal keratoconjunctivitis (VKC). When results were stratified in terms of the atopic status of the patient, it was clear that the allergic patients responded better to cromolyn sodium than did those in whom allergic (IgE-mediated) factors appeared unimportant in the disease process.     

Antiinflammatory therapy for dry eye

PURPOSE: To present evidence establishing the relationship between inflammation and dry eye and supporting the use of antiinflammatory therapy for dry eye. DESIGN: Analysis of literature. METHODS: Research studies that evaluated inflammation in dry eye pathogenesis and clinical trials of antiinflammatory therapies for dry eye were reviewed. RESULTS: There is increasing evidence that decreased tear secretion, decreased tear turnover, and desiccation promote inflammation on the ocular surface. An increase in soluble mediators (cytokines and proteases) in the tear fluid, adhesion molecule expression by the conjunctival epithelium, and T-cell infiltration of the conjunctiva have been observed in dry eye patients. This inflammation appears to have a role in the pathogenesis of the ocular surface epithelial disease, termed keratoconjunctivitis sicca (KCS), that develops in dry eye. Clinical improvement of KCS has been observed after therapy with antiinflammatory agents including corticosteroids, cyclosporin and doxycycline. Cyclosporin A emulsion was approved by the Food and Drug Administration as therapy for dry eye. Randomized placebo-controlled FDA clinical trials showed that cyclosporine A was superior to vehicle in stimulating aqueous tear production, decreasing corneal punctuate fluorescein staining, reducing symptoms of blurred vision, and decreasing artificial tear use in patients with KCS. No ocular or systemic toxicity was observed from this medication. CONCLUSIONS: Ocular surface and lacrimal gland inflammation has been identified in dry eye that plays a role in the pathogenesis of KCS. Antiinflammatory therapy has efficacy for treating KCS. Cyclosporin A is the first FDA approved therapy for this indication. It improved signs and symptoms of KCS, and it is safe for long-term use.     

Clinical trial of sustained-release artificial tears in keratoconjunctivitis sicca and Sj?gren's syndrome

The effect of sustained-release artificial tear inserts on symptoms and signs of reduced tear production in keratoconjunctivitis sicca (KCS) was evaluated in an open clinical trial including 30 patients. A significant relief of sicca symptoms and a decrease in keratoconjunctival staining were seen in 10 patients fulfilling the study, whereas no significant effect on Schirmer test and tear break-up-time could be detected, neither in patients with pure KCS nor with KCS as a manifestation of Sj?gren's syndrome. Twenty patients (67%) withdrew due to adverse effects, which were reported in total 80% of the patients. Absence of measurable tear secretion predicted treatment failure. Due to the frequent side effects, the artificial tear inserts cannot be recommended as a first line treatment in KCS patients.     

Efficacy and safety of desonide phosphate for the treatment of allergic conjunctivitis

PURPOSE: To study the safety and efficacy of the topical corticosteroid, desonide 0.25% ophthalmic solution, for inhibition of the clinical allergic reaction induced by conjunctival provocation (CPT) and for the treatment of seasonal allergic conjunctivitis (SAC). METHODS: For the CPT study, 12 allergic but inactive patients were exposed in both eyes to increasing doses of a specific allergen until a positive bilateral, symmetrical early- and late-phase reaction was obtained. After 2 weeks the last positive dose was readministrated and their positive response confirmed. After an additional 2 weeks, CPT was performed 30 minutes after topical administration of desonide in one eye and placebo in the contralateral eye (Group A) or after topical desonide or placebo four times a day for 2 days (Group B). Clinical signs and symptoms were recorded after 15, 30, and 60 minutes, and after 6 hours. Regarding the seasonal study, 96 patients with active SAC were treated bilaterally with either desonide or fluorometholone for 3 weeks, and allergic signs and symptoms evaluated at regular intervals. The safety of the drugs was assessed by identification of any side effects or adverse events of any kind. RESULTS: For the CPT study: individual itching and redness, and the sum score for signs and symptoms were all statistically (p < 0.05) and clinically (greater than 1 change between treated eyes) significantly lower in desonide versus placebo eyes. Both early- and late-phase reactions were reduced by desonide pretreatment. Seasonal study: desonide and fluorometholone were both highly effective in reducing itching, tearing, and conjunctival hyperemia over time (p < 0.0001). Both drugs appeared safe, with no statistically significant changes in IOP observed with either treatment. CONCLUSIONS: Desonide has a significant therapeutic effect on both the induced conjunctival early- and late-allergic reaction and in active SAC. It was also safe, with no side effects such as increases in intraocular pressure observed by physician or patient.     

Topical cyclosporine inhibits conjunctival epithelial apoptosis in experimental murine keratoconjunctivitis sicca

PURPOSE: Increased apoptosis in the conjunctival epithelium has been observed in experimental murine keratoconjunctivitis sicca (KCS). Topical cyclosporine (CsA) has been noted to reduce conjunctival epithelial apoptosis in chronic canine and human KCS. The purpose of this study is to determine if topical CsA treatment inhibits conjunctival epithelial apoptosis in a murine model of KCS. METHODS: Dry eye was induced in 3 groups of C57BL6 mice by subcutaneous injection of scopolamine TID and exposure to an air draft and low-humidity environment for 16 hours per day for 12 days. The dry eye control group received no topical treatment; a second group received 1 microL of 0.05% CsA topically TID (dry eye + CsA); and the third group received 1 microL of the castor oil vehicle of CsA topically TID (dry eye + vehicle). Normal mice were used as untreated controls. After 12 days, the mice were killed, and the right eyes and eyelids were excised, frozen, and cryosectioned. Transmission electron microscopy (TEM) was performed on conjunctival and corneal samples taken from the left eyes. Apoptosis was detected in frozen sections with the ApopTag (ISOL) In Situ Oligo Ligation Kit, which specifically detects DNA fragmentation. Immunohistochemical staining was performed to detect activated caspase-3. Conjunctival goblet cell number was counted in tissue sections stained with period acid Schiff (PAS) reagent. These assays were performed on 2 separate sets of mice. RESULTS: Compared with untreated controls and dry eye mice receiving CsA, the number of ISOL-positive epithelial cells in the bulbar and tarsal conjunctiva was significantly greater in the dry eye control and dry eye mice + vehicle groups (P < 0.01 for both groups). There was no significant difference in the number of ISOL-positive conjunctival epithelial cells between the dry eye control and dry eye + vehicle mice. There was no significant difference in ISOL-positive cells in the corneal epithelium between the untreated controls and the 3 treatment groups. Dry eye + CsA mice showed less activated caspase-3 staining than the dry eye control and the dry eye + vehicle groups. TEM showed loss of superficial differentiated cells and extensive nuclear fragmentation characteristic of apoptosis in the dry eye control and dry eye + vehicle groups but not in the dry eye + CsA group. There was significant loss of goblet cells in the bulbar and tarsal conjunctivae of the dry eye control and the dry eye + vehicle groups compared with untreated controls and the dry eye + CsA group. CONCLUSIONS: Topical CsA significantly reduced conjunctival epithelial apoptosis and protected against goblet cell loss in experimental murine KCS. Inhibition of apoptosis appears to be a key mechanism for the therapeutic effect of CsA for KCS.     

N-acetyl-aspartyl glutamic acid (NAAGA) topical eyedrops in the treatment of Giant Papillary Conjunctivitis (GPC)

Giant Papillary Conjunctivitis (GPC) is a conjunctival inflammatory condition associated with contact lens wear. The etiology is still unknown and no adequate treatment is found. Mastcell stabilizing drugs are useful in the treatment of chronic inflammatory processes. The effect of 6% N-acetyl-aspartyl glutamic acid (NAAGA), a mastcell stabilizing agent, in a double-masked comparative trial with placebo in the treatment of GPC is reported.Seventeen patients with symptomatic GPC were treated over a four week period, eyes were randomized to receive NAAGA or placebo. A decrease in symptoms was found for both eyes. No significant difference of clinical symptoms and signs were observed between NAAGA or placebo treated eyes. These results suggest a wash effect of placebo in GPC. Tear C3a showed a increased level compared to normals but no statistically significance was observed in our study. The results of this study indicate that mastcell stabilization in GPC has little effect and treatment should be focused more on inflammatory mediators released because of mechanical stimuli.     

A phase III,placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis

AIM: To compare the efficacy and safety of levofloxacin 0.5% ophthalmic solution (Quixin) with placebo for treatment of bacterial conjunctivitis. METHODS: In this prospective, randomised, placebo controlled, double masked, multicentre study, 249 patients with bacterial conjunctivitis received either 0.5% levofloxacin (n = 126) or placebo (n = 123) for 5 days, administered every 2 hours on days 1-2, then every 4 hours on days 3-5. Cultures were obtained and signs/symptoms evaluated at baseline, interim, and final visits. The end point was the last evaluable observation. Primary microbial outcomes were based on culture results; clinical outcomes were based on resolution of cardinal signs. RESULTS: 117 patients (60 levofloxacin, 57 placebo) were evaluated. Microbial eradication rates were significantly greater with levofloxacin at all time points, reaching 90% at end point. In a subgroup analysis, differences in eradication rates at end point were most pronounced in children but were also statistically significant for levofloxacin in adults. Clinical cure rates were significantly greater with levofloxacin at final visit and end point. Statistically significant differences favouring levofloxacin were measured at end point for resolution of conjunctival discharge, bulbar conjunctival injection, palpebral conjunctival injection, burning/stinging, itching, and photophobia. Adverse events were similar between groups. Safety composite scores analysed by age indicated significantly fewer children on levofloxacin experienced worsening symptoms. CONCLUSIONS: Levofloxacin 0.5% ophthalmic solution is safe and effective for treatment of bacterial conjunctivitis.     

Correlations Among Symptoms, Signs, and Clinical Tests in Evaporative-Type Dry Eye Disease Caused by Meibomian Gland Dysfunction (MGD)

Purpose: To evaluate changes in symptoms, objective tests, and signs after medical treatment of subjects with evaporative-type dry eye disease (EDE) caused by Meibomian gland dysfunction (MGD), and to analyze correlations among symptoms, signs and test results in the worse eyes (W-eyes) of the subjects. Methods: Prospective clinical study of 21 symptomatic subjects with EDE caused by MGD. Subjects who were diagnosed with EDE in a first visit were treated for 6 weeks and re-evaluated in a second visit. The differences between initial and second visits were evaluated. Correlations among clinical symptoms, signs, and test results were performed using the data of the W-eyes. Variables evaluated included: dry eye symptoms, best corrected visual acuity (BCVA), contrast sensitivity, conjunctival hyperemia, phenol red thread test, tear break-up time (TBUT), tear meniscus height (TMH), corneal fluorescein and conjunctival rose Bengal staining, tear lysozyme concentration, Schirmer test, and lid margin assessment. Results: All items evaluated improved after treatment, but only conjunctival hyperemia and TMH improved significantly. TBUT and lid margin changes improved, but still remained abnormal. There were significant correlations among symptoms questionnaires and some clinical tests (TBUT, conjunctival hyperemia, TMH, and conjunctival rose Bengal staining). Conclusion: Despite the instability of the tear film and lid margin alterations that continued after treatment, subjects with MGD improved symptomatically. The low degree of correlations among W-eye signs, symptoms, and tests reflects the independency of symptoms and signs in this complex pathology.     

Keratoconjunctivitis sicca in juvenile rheumatoid arthritis

PURPOSE: To compare the symptoms, signs, and results of objective tests for keratoconjunctivitis sicca (KCS) in patients with juvenile rheumatoid arthritis (JRA) and controls. METHODS: Sixty-four patients with JRA and 64 age- and sex-matched controls were compared in terms of symptoms, signs, and results of objective tests for KCS. Relation between tear film breakup time (TBUT), Schirmer test results, and JRA-related variables such as age of onset, duration, and type of JRA; presence of antinuclear antibodies (ANAs); and history of uveitis were evaluated. Analysis of variance, multivariate regression analysis, Kruskall-Wallis, Student t tests, and chi tests were used for statistical analysis. RESULTS: Twelve and a half percent of patients with JRA complained of dry eye symptoms compared with 1.5% of the controls (P = 0.031). Dry eye signs were detected in 10.9% of patients with JRA compared with 1.5% of controls (P = 0.038). TBUT and Schirmer test results were lower in the JRA group than in controls (P = 0.032 and P = 0.029, respectively). Seven patients (10.9%) had definite and 1 (1.5%) had probable diagnosis of KCS in the JRA group compared with no children in the control group (P = 0.034). Within the JRA group, Schirmer test and TBUT results were significantly lower in male patients and ones with longer duration of disease. CONCLUSIONS: The prevalence of symptoms, signs, and definite diagnosis of KCS is higher and basal tear secretion and tear film stability are lower in children with JRA than in controls. Among children with JRA, male sex and longer duration of disease are independent risk factors for having decreased basal tear secretion and tear film stability.     

Symptomatic dry eye treatment with autologous platelet-rich plasma

BACKGROUND: Autologous platelet-rich plasma (PRP) has been proven to be very effective on tissue regeneration and wound healing. Here we investigate the potential use of PRP in the treatment of symptomatic dry eye. METHODS: Eighteen consecutive patients with symptomatic dry eye were treated with topical PRP and followed up for 1 month. Disappearance of subjective symptoms, increase in best corrected visual acuity, tear meniscus, tear breakup time, decrease in inflammation, fluorescein staining and improvement in impression cytology were measured. RESULTS: Symptoms improved significantly in 89% of the patients, 28% improved at least 1 line of best corrected visual acuity. A significant improvement on lachrymal meniscus and conjunctival hyperemia and a decrease or disappearance of corneal fluorescein staining were observed. Impression cytology revealed a significant increase in conjunctival goblet cells. CONCLUSION: Treatment of patients suffering from significant dry eye symptoms with autologous RPR proved to be very effective, improving both patient symptoms and major clinical signs.     

Flow cytometric analysis of inflammatory markers in conjunctival epithelial cells of patients with dry eyes

PURPOSE: To investigate in impression cytology (IC) specimens the expression of inflammatory and apoptosis-related markers by conjunctival epithelial cells from patients with dry eye as a rationale for treatment with topical cyclosporine. METHODS: Immunologic anomalies were identified at baseline, before treatment with the masked medication, in a homogeneous series of patients with dry eye syndrome, who were enrolled in a large European multicenter clinical trial (Cyclosporin A Dry Eye Study; Allergan, Irvine, CA). IC specimens were collected in 243 patients with moderate to severe keratoconjunctivitis sicca (KCS), with or without Sjogren's syndrome (SS). Fifty normal subjects were separately examined to provide normal control values. Specimens were analyzed in a masked manner by flow cytometry, using antibodies directed to markers of the immune system and/or apoptotic pathway: HLA DR, CD40, CD40 ligand, Fas, and APO2.7. Levels of expression were quantified, and results were compared with those obtained in the 50 normal patients. RESULTS: One hundred sixty-nine specimens were successfully interpreted at baseline, including 41% from patients with SS. A highly significant increase of HLA DR expression by conjunctival cells was found in KCS-affected eyes compared with normal eyes, which did not express this marker or did so very weakly. HLA DR expression in eyes with SS was significantly higher than in KCS-affected eyes without SS. Fas and APO2.7 were found at low levels in all normal and KCS-affected eyes. CD40 and CD40 ligand expressions were significantly increased in eyes with KCS compared with normal eyes. HLA DR, CD40 and Fas were found at significantly higher levels in the SS group than in the non-SS group. CONCLUSIONS. Conjunctival cells from patients with dry eye with moderate to severe KCS, with or without SS, overexpress inflammatory and apoptosis-related markers. Whether inflammation is a primary phenomenon in KCS or is the consequence of repetitive abrasion of the ocular surface after tear film deficiency remains to be determined. These data, nevertheless, support the use of immunomodulatory and/or anti-inflammatory drugs in the treatment of patients with KCS.     

Impression cytology

Impression cytology refers to the application of cellulose acetate filter material to the ocular surface to remove the superficial layers of the conjunctival epithelium. Impression cytology has been found to be useful in assessing the ocular surface in various dry eye disorders, such as keratoconjunctivitis sicca (KCS), cicatricial ocular pemphigoid, and vitamin A deficiency. The technique is noninvasive, is easy to perform, causes minimal discomfort to the patient, and can be used to follow changes in the conjunctival ocular surface over time. With this method, the morphology of the conjunctival ocular surface can be studied and the degree of squamous metaplasia assessed. A specific criteria based on the appearance of the epithelial cells and the density of the goblet cells can be used to assign a grade (0-3) to the ocular surface. The grade of the ocular surface is related to the degree of squamous metaplasia and usually parallels the severity of clinical disease. Impression cytology can also be used to differentiate between various dry eye disorders. Disorders that are extrinsic or environmental (such as KCS) often affect the exposed interpalpebral ocular surface before the more protected inferior palpebral ocular surface. Intrinsic surface disorders (such as ocular pemphigoid) affect the palpebral, as well as the bulbar ocular surfaces, early in the disease.     

A multicentre,double‐masked,randomized, controlled trial assessing the effect of oral supplementation of omega‐3 and omega‐6 fatty acids on a conjunctival inflammatory marker in dry eye patients

Purpose: To determine whether oral supplementation with omega‐3 and omega‐6 fatty acids can reduce conjunctival epithelium expression of the inflammatory marker human leucocyte antigen‐DR (HLA‐DR) in patients with dry eye syndrome (DES). Methods: This 3‐month, double‐masked, parallel‐group, controlled study was conducted in nine centres, in France and Italy. Eligible adult patients with mild to moderate DES were randomized to receive a placebo containing medium‐chain triglycerides or treatment supplement containing omega‐3 and omega‐6 fatty acids, vitamins and zinc. Treatment regimen was three capsules daily. Impression cytology (IC) was performed at baseline and at month 3 to assess the percentage of cells expressing HLA‐DR and to evaluate fluorescence intensity, an alternate measure of HLA‐DR. Dry eye symptoms and objective signs were also evaluated. Analyses were performed on the full analysis set (FAS) and per‐protocol set (PPS). Results: In total, 138 patients were randomized; 121 patients with available IC were included in the FAS, and of these, 106 patients had no major protocol deviations (PPS). In the PPS, there was a significant reduction in the percentage of HLA‐DR‐positive cells in the fatty acids group (p = 0.021). Expression of HLA‐DR as measured by fluorescence intensity quantification was also significantly reduced in the fatty acids group [FAS (p = 0.041); PPS (p = 0.017)]. No significant difference was found for the signs and symptoms, but there was a tendency for improvement in patients receiving the fatty acids treatment. Conclusion: This study demonstrates that supplementation with omega‐3 and omega‐6 fatty acids can reduce expression of HLA‐DR conjunctival inflammatory marker and may help improve DES symptoms.     

Scanning electron microscopy of conjunctival surfaces in patients with ocular cicatricial pemphigoid

The conjunctival surfaces of ten patients with active, ocular cicatricial pemphigoid, three patients with drug-controlled ocular cicatricial pemphigoid, and six patients with normal conjunctivas were studied using scanning electron microscopy. A homogeneous granular sheet of amorphous mucin-like material was observed covering extensive areas of the conjunctiva in eight of ten patients with active ocular cicatricial pemphigoid. This sheet of amorphous material was absent on drug-controlled ocular cicatricial pemphigoid and normal conjunctival specimens. Our study demonstrates that patients with active ocular cicatricial pemphigoid possess ocular surface mucus that appears thicker and more continuous than normal ocular mucus when observed with scanning electron microscopy. This observation is in agreement with clinical observations of thick mucus strands in the inferior fornix of patients with active ocular cicatricial pemphigoid.     

结膜松弛症的临床及病理研究

目的探讨结膜松弛症的临床特征及组织病理学改变。方法收集结膜松弛症患者26例（39只眼）的相关临床资料,并进行回顾性分析;对患病组26例（39只眼）结膜松弛症患者松弛结膜组织和对照组15例（15只眼）单纯白内障患者球结膜组织进行病理组织学检查,对照观察两组样本组织病理改变。结果结膜松弛症患者多为中老年人,性别比较差异无显著性,均为双眼发病,均有溢泪与干眼症状,不同程度的多余球结膜堆积于下眼睑与眼球之间,泪膜破裂时间（BUT）〈3S,角膜荧光素染色阳性。组织病理学改变：对照组有14只眼为正常的结膜改变,患病组39只眼中有16只眼为慢性非肉芽肿性结膜炎,17只眼为弹性组织变性。结论结膜松弛症患者多为中老年人,主要表现为溢泪与干眼症状,选择合适的手术可以有效的改善患者的病情;其主要病理改变为弹性组织变性,慢性非肉芽肿性结膜炎及炎性细胞浸润等。     

Randomised controlled trial of topical ciclosporin A in steroid dependent allergic conjunctivitis

AIM: To evaluate the efficacy, safety, and therapeutic effect of topical ciclosporin A 0.05% as a steroid sparing agent in steroid dependent allergic conjunctivitis. METHODS: Prospective, randomised, double masked, placebo controlled trial comparing signs, symptoms, and the ability to reduce or stop concurrent steroid in steroid dependent atopic keratoconjunctivitis and vernal keratoconjunctivitis using 0.05% topical ciclosporin A compared to placebo. Steroid drop usage per week (drug score), symptoms, and clinical signs scores were the main outcome measures. RESULTS: The study included an enrolment of 40 patients, 18 with atopic keratoconjunctivitis and 22 with vernal keratoconjunctivitis. There was no statistical significant difference in drug score, symptoms, or clinical signs scores between the placebo and ciclosporin group at the end of the treatment period. No adverse reactions to any of the study formulations were encountered. CONCLUSIONS: Topical ciclosporin A 0.05% was not shown to be of any benefit over placebo as a steroid sparing agent in steroid dependent allergic eye disease.     

Diagnostic tests for dry eye disease in normals and dry eye patients with and without Sj?gren's syndrome.

In order to compare the diagnostic tests for dry eye disease and the results of conjunctival impression cytology, we examined three groups of eyes: 146 eyes of normal controls, 108 eyes of keratoconjunctivitis sicca (KCS) patients without Sj?gren's syndrome (SS) and 102 eyes of patients with SS. The clinical tests (break-up time, Schirmer test, Rose Bengal staining) and conjunctival impression cytology specimens from the superior part of the bulbar conjunctiva were evaluated from all the eyes. Our results showed that the patients with KCS without SS have abnormal lacrimal tests (p < 0.001) without changes in impression cytology [nucleo/cytoplasmic ratio (N/C), p > 0.1]. The patients with KCS and SS have also abnormal lacrimal tests (p < 0.01), and their epithelial cells presented squamous metaplasia (N/C, p < 0.001). The goblet cell number remained unchanged in the three groups (p > 0.1).     

普拉洛芬联合玻璃酸钠治疗中重度干眼的短期疗效

目的：评估普拉洛芬滴眼液联合玻璃酸钠滴眼液对中重度干眼治疗的短期临床疗效及对患者心理状况的影响。

方法：选取2018-01/12于我院眼科就诊并治疗的中重度干眼患者318例,采用随机数字表法将患者分为试验组(238例)和对照组(80例),其中对照组采用玻璃酸钠滴眼液治疗,试验组采用普拉洛芬滴眼液联合玻璃酸钠滴眼液治疗。治疗前、治疗后7、14、28d问卷调查患者的自觉症状及体征评分,检查结膜充血程度、泪膜破裂时间、角膜荧光素染色及泪液分泌情况,评估患者焦虑和抑郁程度。

结果：在患者的自觉症状及体征评分、结膜充血程度、泪膜破裂时间、角膜荧光素染色及泪液分泌方面,试验组在治疗后7d即有显著改善,且随着治疗时间的延长,效果更加显著,对照组在治疗后14d或28d逐渐好转; 同一治疗时间点,试验组疗效均明显优于对照组(P<0.05)。治疗后随着病情的好转,患者的焦虑或抑郁症状得到改善,试验组治疗后7d即有明显好转,对照组治疗后14d或28d逐渐好转; 同一治疗时间点,相比对照组,试验组患者的焦虑或抑郁程度均显著减轻(P<0.05)。

结论：普拉洛芬滴眼液联合玻璃酸钠滴眼液治疗干眼症起效快且疗效显著,患者自觉症状及体征显著改善,结膜充血和角膜荧光素染色减轻,泪膜破裂时间延长,泪液分泌量增加,患者焦虑或抑郁程度显著好转。