Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study.

PURPOSE: To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0% compared with placebo in subjects with dry eye disease. DESIGN: Prospective, randomized, double-masked, placebo-controlled, parallel arm, multicenter clinical trial. PARTICIPANTS: A total of 588 adult subjects with dry eye disease. METHODS: Eligible subjects were randomized 1:1 to receive topically administered lifitegrast (5.0%) or placebo (vehicle) twice daily for 84 days after a 14-day open-label placebo run-in period. After enrollment (day 0), subjects were evaluated at days 14, 42, and 84. Key objective (fluorescein and lissamine staining scores [Ora scales]) and subjective (Ocular Surface Disease Index [OSDI], 7-item visual analog scale, and ocular discomfort score [Ora scale]) measures were assessed at all visits. MAIN OUTCOME MEASURES: The primary objective efficacy measure (sign) was mean change from baseline inferior corneal staining score (ICSS) at day 84. The co-primary subjective efficacy measure (symptom) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index (VR-OSDI). Supportive measures included corneal fluorescein scores (superior, central, total region) and conjunctival lissamine scores (nasal, temporal, total region) and symptom scores at day 84. RESULTS: The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo (P = 0.0007). Lifitegrast significantly reduced corneal fluorescein staining (superior, P = 0.0392; total cornea, P = 0.0148) and conjunctival lissamine staining (nasal, P = 0.0039; total conjunctiva, P = 0.0086) at day 84 versus placebo. Significant (P < 0.05) improvements in nasal and total lissamine scores were observed at day 14 and maintained through day 84. The study did not meet the co-primary subjective VR-OSDI measure (P = 0.7894). However, significant improvements were observed at day 84 in ocular discomfort (P = 0.0273) and eye dryness (P = 0.0291), the most common and severe symptoms reported at baseline in both groups. There were no unanticipated or serious ocular adverse events (AEs). The most frequent reported ocular AEs were transient intermittent instillation site symptoms (irritation, discomfort) primarily on the initial lifitegrast dose at day 0. CONCLUSIONS: Lifitegrast ophthalmic solution 5.0% significantly reduced corneal fluorescein and conjunctival lissamine staining and improved symptoms of ocular discomfort and eye dryness compared with placebo when administered twice daily over 84 days.

Confocal microscopy of central toxic keratopathy.

PURPOSE: To examine the confocal microscopic findings in a case of late-onset central toxic keratopathy. METHODS: A 46-year-old man with central toxic keratopathy 2 months after IntraLASIK underwent confocal microscopy to examine the cellular findings within the flap interface. RESULTS: The confocal microscopy in central toxic keratopathy reveals activated keratocytes without aggregation of inflammatory cells. CONCLUSIONS: The lack of inflammatory cells in the interface is consistent with the noninflammatory nature of central toxic keratopathy. To our knowledge, this is the first report of confocal microscopy in presumed central toxic keratopathy.

Ocular infection secondary to gemella.

PURPOSE: To report four cases of ocular infection caused by Gemella species. METHODS: Microbial identification was carried out using the MicroScan Walkaway system (Dade Behring) and/or Vitek-2 (bioMérieux) and susceptibility testing with either Kirby-Bauer disc diffusion and/or Vitek-2. The paper is presented as an interventional case report. RESULTS: Four patients developed infection due to Gemella species. All responded to vancomycin or fortified aminoglycosides and broad-spectrum antibiotics. CONCLUSION: Gemella spp. can cause opportunistic infections in the eye.

Surgical management of conjunctival lymphangiectasis by conjunctival resection.

PURPOSE: To report the treatment of symptomatic conjunctival lymphangiectasis with conjunctival resection. DESIGN: Interventional case series. METHODS: Retrospective review of three cases of patients with symptomatic unilateral conjunctival lymphangiectasis who had conjunctival resection of the involved tissue down to bare sclera. RESULTS: The surgical area reepithelialized without recurrence of the lymphatics. In all cases the patients have remained asymptomatic for at least 14 months. CONCLUSION: Conjunctival resection for symptomatic lymphangiectasis can be a successful therapeutic option for this condition.

Ocular complications associated with the use of cosmetic contact lenses from unlicensed vendors.

PURPOSE: To call attention to the unauthorized sale of cosmetic contact lenses, resulting in ocular complications. DESIGN Observational case report. METHODS: Retrospective, observational, clinical practice setting. RESULTS: Six patients (five female and one male) were seen urgently for acute eye pain and redness after wearing cosmetic plano contact lenses. None of the patients had previously worn a contact lens or spectacle correction. None of the lenses were dispensed by eye care professionals. One patient developed pseudomonal keratitis, ultimately requiring penetrating keratoplasty for visual rehabilitation. CONCLUSIONS: Colored contact lenses are being dispensed without a prescription or fitting from unlicensed vendors, such as cosmetics, convenience, and accessory stores. Lenses are sold individually and without care instructions. Consequently, uninformed lens wearers are experiencing acute, vision-threatening infections and inflammation.