Back to resultsEfficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ecabet 2.83%
Ecabet 3.70%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
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
Sites / Locations
- Central Maine Eye Care
- Andover Eye Associates
- Eyesight Ophthalmic Services, PA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Ecabet 2.83%
Ecabet 3.70%
Vehicle
Arm Description
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
One drop of vehicle in study eye 4 times daily for 90 days.
Outcomes
Primary Outcome Measures
Ocular discomfort
Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Tear Film Break-up Time (TFBUT)
Group mean change in time to tear break-up from pre-CAE to post-CAE.
Blink Rate
Group mean change in blinks/min from pre-CAE to post-CAE.
Secondary Outcome Measures
Full Information
NCT ID
NCT00198536
First Posted
September 13, 2005
Last Updated
March 13, 2013
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00198536
Brief Title
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
Official Title
Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ecabet 2.83%
Arm Type
Experimental
Arm Description
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Arm Title
Ecabet 3.70%
Arm Type
Experimental
Arm Description
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop of vehicle in study eye 4 times daily for 90 days.
Intervention Type
Drug
Intervention Name(s)
Ecabet 2.83%
Intervention Type
Drug
Intervention Name(s)
Ecabet 3.70%
Intervention Type
Drug
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
Ocular discomfort
Description
Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Time Frame
Day 91
Title
Tear Film Break-up Time (TFBUT)
Description
Group mean change in time to tear break-up from pre-CAE to post-CAE.
Time Frame
Day 91
Title
Blink Rate
Description
Group mean change in blinks/min from pre-CAE to post-CAE.
Time Frame
Day 91
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Central Maine Eye Care
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01840
Country
United States
Facility Name
Eyesight Ophthalmic Services, PA
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
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