PURPOSE: To investigate the efficacy and safety of an investigational integrin antagonist (SAR 1118) ophthalmic solution compared to placebo (vehicle) in subjects with dry eye disease. DESIGN: Multicenter, prospective, double-masked, placebo-controlled trial. METHODS:A total of 230 dry eye subjects selected with use of a controlled adverse environment were randomized 1:1:1:1 to receive SAR 1118 (0.1%, 1.0%, 5.0%) or placebo eye drops twice daily for 84 days. Principal eligibility criteria included exacerbation in corneal staining and ocular symptoms with controlled adverse environment exposure, no active lid margin disease, and Schirmer test (mm/5 min) >1 and <10. Ocular signs and symptoms (Ocular Surface Disease Index, OSDI) were assessed at day 14, 42, and 84. No supplemental artificial tears were allowed. Primary outcome measure was inferior corneal staining score at day 84. RESULTS: A dose response for the corneal staining score (P = .0566) was observed for SAR 1118 at day 84 compared to placebo. Mean change from baseline to day 84 showed significant improvements (P < .05) in corneal staining score, total OSDI, and visual-related function OSDI scores for SAR 1118 compared to placebo; improvements in tear production and symptoms were observed as early as day 14 (P < .05). Adverse events were mild and transient in nature with no serious ocular adverse events. SAR 1118 5.0% showed increased instillation site adverse events relative to placebo but were limited to the initial dose. CONCLUSION:SAR 1118 demonstrated improvements in signs and symptoms of dry eye compared to placebo and appears safe when administered over 84 days.
RCT Entities:
PURPOSE: To investigate the efficacy and safety of an investigational integrin antagonist (SAR 1118) ophthalmic solution compared to placebo (vehicle) in subjects with dry eye disease. DESIGN: Multicenter, prospective, double-masked, placebo-controlled trial. METHODS: A total of 230 dry eye subjects selected with use of a controlled adverse environment were randomized 1:1:1:1 to receive SAR 1118 (0.1%, 1.0%, 5.0%) or placebo eye drops twice daily for 84 days. Principal eligibility criteria included exacerbation in corneal staining and ocular symptoms with controlled adverse environment exposure, no active lid margin disease, and Schirmer test (mm/5 min) >1 and <10. Ocular signs and symptoms (Ocular Surface Disease Index, OSDI) were assessed at day 14, 42, and 84. No supplemental artificial tears were allowed. Primary outcome measure was inferior corneal staining score at day 84. RESULTS: A dose response for the corneal staining score (P = .0566) was observed for SAR 1118 at day 84 compared to placebo. Mean change from baseline to day 84 showed significant improvements (P < .05) in corneal staining score, total OSDI, and visual-related function OSDI scores for SAR 1118 compared to placebo; improvements in tear production and symptoms were observed as early as day 14 (P < .05). Adverse events were mild and transient in nature with no serious ocular adverse events. SAR 1118 5.0% showed increased instillation site adverse events relative to placebo but were limited to the initial dose. CONCLUSION:SAR 1118 demonstrated improvements in signs and symptoms of dry eye compared to placebo and appears safe when administered over 84 days.
Authors: Anastasia Alex; Austin Edwards; J Daniel Hays; Michelle Kerkstra; Amanda Shih; Cintia S de Paiva; Stephen C Pflugfelder Journal: Invest Ophthalmol Vis Sci Date: 2013-05-07 Impact factor: 4.799
Authors: Min Zhong; Thomas R Gadek; Minna Bui; Wang Shen; John Burnier; Kenneth J Barr; Emily J Hanan; Johan D Oslob; Chul H Yu; Jiang Zhu; Michelle R Arkin; Marc J Evanchik; W Mike Flanagan; Ute Hoch; Jennifer Hyde; Saileta Prabhu; Jeffrey A Silverman; Jasmin Wright Journal: ACS Med Chem Lett Date: 2012-01-31 Impact factor: 4.345
Authors: Richard Abelson; Keith J Lane; John Rodriguez; Patrick Johnston; Endri Angjeli; George Ousler; Douglas Montgomery Journal: Clin Ophthalmol Date: 2012-11-13