NCT01421498

Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

A Phase 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (OPUS-1)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 588 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.

Conditions

• Keratoconjunctivitis Sicca
• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Lifitegrast	Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
DRUG	Placebo	Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks

Timeline

• Start date: 2011-08-29
• Primary completion: 2012-04-28
• Completion: 2012-04-28
• First posted: 2011-08-22
• Last updated: 2021-06-11
• Results posted: 2017-02-24

Locations

13 sites across 1 country: United States