Status:
COMPLETED
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
Eligibility Criteria
Inclusion
- Agree to avoid systemic \& topical ophthalmic meds \& disallowed meds
- Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
- Diagnosis of moderate dry eye syndrome
Exclusion
- Uncontrolled ocular or systemic disease that could interfere with study
- Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
- Contraindications or hypersensitivity to use of study meds or components
- Wear contact lenses
- Secondary dry eye to surgery
- Eye surgery (including laser) within 6 months
- Use of systemic or topical ophthalmic meds within 14 days
- Punctal plugs in one or both eyes in place for \<45 days
- Permanent occlusion of the lacrimal puncta
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00198536
Start Date
April 1 2005
End Date
December 1 2005
Last Update
March 14 2013
Active Locations (3)
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1
Central Maine Eye Care
Lewiston, Maine, United States, 04240
2
Andover Eye Associates
Andover, Massachusetts, United States, 01840
3
Eyesight Ophthalmic Services, PA
Dover, New Hampshire, United States, 03820