Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
1 other identifier
interventional
38
1 country
1
Brief Summary
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2008
Shorter than P25 for phase_2
1 active site
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
August 13, 2008
CompletedFirst Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2009
CompletedResults Posted
Study results publicly available
September 14, 2020
CompletedSeptember 14, 2020
August 1, 2020
5 months
September 19, 2008
August 11, 2020
August 25, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline, Day 42
Percentage of Participants With at Least One Adverse Event
52 days
Secondary Outcomes (1)
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
Baseline, 42 days
Study Arms (1)
bromfenac ophthalmic solution 0.06%
EXPERIMENTALbromfenac ophthalmic solution 0.06% bilaterally twice a day
Interventions
bromfenac ophthalmic solution 0.06% bilaterally twice a day
Eligibility Criteria
You may qualify if:
- Subjects 18 years of age or older
You may not qualify if:
- No active ocular conditions of disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Participants could co-administer Refresh Plus OTC eyedrops as needed during treatment/follow-up. Only 29 participants dosed all 42 days. Environmental factors influencing dry eye (eg, temperature, humidity, season, geography) were not controlled.
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Tim McNamara, PharmD
ISTA Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 25, 2008
Study Start
August 13, 2008
Primary Completion
January 14, 2009
Study Completion
January 14, 2009
Last Updated
September 14, 2020
Results First Posted
September 14, 2020
Record last verified: 2020-08