Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00758784
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 5.1
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: bromfenac ophthalmic solution 0.06%	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Aug 13, 2008
• Actual Primary Completion Date: Jan 14, 2009
• Actual Study Completion Date: Jan 14, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bromfenac ophthalmic solution 0.06% bromfenac ophthalmic solution 0.06% bilaterally twice a day	Drug: bromfenac ophthalmic solution 0.06%; bromfenac ophthalmic solution 0.06% bilaterally twice a day

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye [Baseline, Day 42]

   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.

2. Percentage of Participants With at Least One Adverse Event [52 days]

Secondary Outcome Measures

1. Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye [Baseline, 42 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects 18 years of age or older

Exclusion Criteria:

• No active ocular conditions of disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISTA Pharmaceuticals, Inc.	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00758784
• Other Study ID Numbers: CL-S&E-0417082-P
• First Posted: Sep 25, 2008
• Last Update Posted: Sep 14, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Bromfenac; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%
Arm/Group Description	bromfenac ophthalmic solution 0.06% bilaterally twice a day
Period Title: Overall Study
STARTED	38
COMPLETED	36
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%
Arm/Group Description	bromfenac ophthalmic solution 0.06% bilaterally twice a day
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.4 (12.1)
Sex: Female, Male (Count of Participants)
Female	28 73.7%
Male	10 26.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants enrolled were included in the analysis population, with last observation carried forward applied for missing values.

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%
Arm/Group Description	bromfenac ophthalmic solution 0.06% bilaterally twice a day
Measure Participants	38
Mean (Standard Deviation) [score on a scale]	-0.65 (0.40)

2. Primary Outcome

Title	Percentage of Participants With at Least One Adverse Event
Time Frame	52 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%
Arm/Group Description	bromfenac ophthalmic solution 0.06% bilaterally twice a day
Measure Participants	38
Count of Participants [Participants]	9 23.7%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants enrolled were included in the analysis population, with last observation carried forward applied for missing values.

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%
Arm/Group Description	bromfenac ophthalmic solution 0.06% bilaterally twice a day
Measure Participants	38
Mean (Standard Deviation) [score on a scale]	-0.84 (0.75)

Adverse Events

Time Frame	52 days
Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%
Arm/Group Description	bromfenac ophthalmic solution 0.06% bilaterally twice a day
All Cause Mortality
	Bromfenac Ophthalmic Solution 0.06%
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Serious Adverse Events
	Bromfenac Ophthalmic Solution 0.06%
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Other (Not Including Serious) Adverse Events
	Bromfenac Ophthalmic Solution 0.06%
	Affected / at Risk (%)	# Events
Total	2/38 (5.3%)
Infections and infestations
Nasopharyngitis	2/38 (5.3%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Please contact sponsor directly for details.