Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome
1 other identifier
interventional
159
1 country
3
Brief Summary
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2005
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMarch 14, 2013
March 1, 2013
8 months
September 13, 2005
March 13, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Ocular discomfort
Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Day 91
Tear Film Break-up Time (TFBUT)
Group mean change in time to tear break-up from pre-CAE to post-CAE.
Day 91
Blink Rate
Group mean change in blinks/min from pre-CAE to post-CAE.
Day 91
Study Arms (3)
Ecabet 2.83%
EXPERIMENTALEcabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Ecabet 3.70%
EXPERIMENTALEcabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
Vehicle
PLACEBO COMPARATOROne drop of vehicle in study eye 4 times daily for 90 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Central Maine Eye Care
Lewiston, Maine, 04240, United States
Andover Eye Associates
Andover, Massachusetts, 01840, United States
Eyesight Ophthalmic Services, PA
Dover, New Hampshire, 03820, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tim McNamara, PharmD
ISTA Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
April 1, 2005
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
March 14, 2013
Record last verified: 2013-03