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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00198536
• Collaborator: (none)
• Enrollment: 159
• Locations: 3
• Arms: 3
• Duration (Months): 8
• Patients Per Site: 53
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Ecabet 2.83%; Drug: Ecabet 3.70%; Drug: Vehicle	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Dec 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ecabet 2.83% Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.	Drug: Ecabet 2.83%
Experimental: Ecabet 3.70% Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.	Drug: Ecabet 3.70%
Placebo Comparator: Vehicle One drop of vehicle in study eye 4 times daily for 90 days.	Drug: Vehicle

Outcome Measures

Primary Outcome Measures

1. Ocular discomfort [Day 91]

   Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE

2. Tear Film Break-up Time (TFBUT) [Day 91]

   Group mean change in time to tear break-up from pre-CAE to post-CAE.

3. Blink Rate [Day 91]

   Group mean change in blinks/min from pre-CAE to post-CAE.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00198536
• Other Study ID Numbers: ISTA-ECBT-CS01
• First Posted: Sep 20, 2005
• Last Update Posted: Mar 14, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Ecabet

Study Results

No Results Posted as of Mar 14, 2013