Back to resultsEfficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ecabet ophthalmic solution
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with dry eye disease
Exclusion Criteria:
- Dry eye disease secondary to surgery
Sites / Locations
- ISTA Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
ecabet ophthalmic solution
Placebo comparator
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test
The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.
Secondary Outcome Measures
Full Information
NCT ID
NCT00667004
First Posted
April 23, 2008
Last Updated
August 18, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00667004
Brief Title
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2008 (Actual)
Primary Completion Date
September 12, 2008 (Actual)
Study Completion Date
September 12, 2008 (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
Efficacy study of ecabet ophthalmic solution in dry eye disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ecabet ophthalmic solution
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
ecabet ophthalmic solution
Intervention Description
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test
Description
The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.
Time Frame
43 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with dry eye disease
Exclusion Criteria:
Dry eye disease secondary to surgery
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
ISTA Pharmaceuticals, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
We'll reach out to this number within 24 hrs