Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: ecabet ophthalmic solution; Drug: placebo

• Registration Number: NCT00667004
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Efficacy study of ecabet ophthalmic solution in dry eye disease

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-22
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Primary Completion: 2008-09-12
• Study Completion: 2008-09-12
• Disposition First Submitted: 2011-09-02
• Disposition First Submitted QC: 2011-09-02
• Disposition First Posted: 2011-09-12
• Status Verified: 2020-08
• Results First Submitted: 2020-08-18
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• Diagnosed with dry eye disease

Exclusion Criteria

• Dry eye disease secondary to surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ecabet ophthalmic solution	ecabet ophthalmic solution
2	placebo	Placebo comparator

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test	43 days	The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.

Trial Locations

Locations (1)

ISTA Pharmaceuticals, Inc.; 🇺🇸 Irvine, California, United States