Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Placebo; Drug: Ecabet

• Registration Number: NCT00370747
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study Start: 2006-09
• Study First Posted: 2006-09-01
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Male/female at least 18 years of age
• Agree to avoid disallowed medications
• Have a diagnosis of dry eye

Exclusion Criteria

• Have chronic systemic inflammation
• Have active seasonal ocular allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Ophthalmic solution in the Study eye four times daily for 90 days.
Ecabet	Ecabet	Ophthalmic solution in the Study eye four times daily for 90 days.

Primary Outcome Measures

Name	Time	Method
Ocular signs and Symptoms	90 days	ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI)	90 days	Questionaire