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

Dry Eye Syndromes Clinical Trial

Official title:

Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198536
• Other study ID #: ISTA-ECBT-CS01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: March 13, 2013
• Start date: April 2005
• Est. completion date: December 2005

Study information

• Verified date: March 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Ecabet 2.83%

• Ecabet 3.70%

• Vehicle

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Eyesight Ophthalmic Services, PA	Dover	New Hampshire
United States	Central Maine Eye Care	Lewiston	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular discomfort	Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE	Day 91	No
Primary	Tear Film Break-up Time (TFBUT)	Group mean change in time to tear break-up from pre-CAE to post-CAE.	Day 91	No
Primary	Blink Rate	Group mean change in blinks/min from pre-CAE to post-CAE.	Day 91	No