Phase 2
N=230
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)
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT00926185 ↗Enrolled (actual)
230
Serious AEs
1.7%
Results posted
Mar 2017
Primary outcome: Primary: Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84 — 2.03; 1.92; 1.83; 2.05 units on a scale — p=0.9381
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lifitegrast (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84 |
2.03; 1.92; 1.83; 2.05 | 0.9381 |
| SECONDARY Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84 |
1.78; 1.82; 1.77; 1.65; 0.25; 0.10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form and HIPAA document
- Willing and able to comply with all study procedures
- Be at least 18 years of age
- Patient-reported history of dry eye in both eyes
- Demonstrate a positive response when exposed to the Controlled Adverse Environment model
- A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
Exclusion Criteria
- Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
- Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period
- Any blood donation or significant loss of blood within 56 days of Visit 1
- Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
- Use of any topical ophthalmic preparations (including tear substitutes) 72 hrs prior to screening assessments and through the entire study period
- Any significant illness that could interfere with study parameters
- History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
- Known history of alcohol and/or drug abuse
Data sourced from ClinicalTrials.gov (NCT00926185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.