NCT00926185

A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)

A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Lifitegrast	Ophthalmic Solution
DRUG	Placebo	Ophthalmic Solution

Timeline

• Start date: 2009-08-03
• Primary completion: 2010-02-18
• Completion: 2010-02-18
• First posted: 2009-06-23
• Last updated: 2021-08-09
• Results posted: 2017-03-06

Locations

5 sites across 1 country: United States