Back to resultsSafety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bromfenac ophthalmic solution 0.06%
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects 18 years of age or older
Exclusion Criteria:
- No active ocular conditions of disease
Sites / Locations
- ISTA Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bromfenac ophthalmic solution 0.06%
Arm Description
bromfenac ophthalmic solution 0.06% bilaterally twice a day
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria.
Percentage of Participants With at Least One Adverse Event
Secondary Outcome Measures
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria.
Full Information
NCT ID
NCT00758784
First Posted
September 19, 2008
Last Updated
August 25, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00758784
Brief Title
Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2008 (undefined)
Primary Completion Date
January 14, 2009 (Actual)
Study Completion Date
January 14, 2009 (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 investigate the safety and efficacy of an 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bromfenac ophthalmic solution 0.06%
Arm Type
Experimental
Arm Description
bromfenac ophthalmic solution 0.06% bilaterally twice a day
Intervention Type
Drug
Intervention Name(s)
bromfenac ophthalmic solution 0.06%
Intervention Description
bromfenac ophthalmic solution 0.06% bilaterally twice a day
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
Description
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria.
Time Frame
Baseline, Day 42
Title
Percentage of Participants With at Least One Adverse Event
Time Frame
52 days
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
Description
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria.
Time Frame
Baseline, 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects 18 years of age or older
Exclusion Criteria:
No active ocular conditions of disease
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
Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
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