Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

Dry Eye Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758784
• Other study ID #: CL-S&E-0417082-P
• Status: Completed
• Phase: Phase 2
• Start date: August 13, 2008
• Est. completion date: January 14, 2009

Study information

• Verified date: August 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 14, 2009
• Est. primary completion date: January 14, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects 18 years of age or older

Exclusion Criteria:

• No active ocular conditions of disease

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• bromfenac ophthalmic solution 0.06%
bromfenac ophthalmic solution 0.06% bilaterally twice a day

Locations

Country	Name	City	State
United States	ISTA Pharmaceuticals, Inc.	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants With at Least One Adverse Event		52 days
Secondary	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.	Baseline, 42 days