Trial Outcomes & Findings for Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease (NCT NCT00758784)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline, Day 42

Results posted on

2020-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Bromfenac Ophthalmic Solution 0.06% bromfenac ophthalmic solution 0.06% bilaterally twice a day
Overall Study STARTED	38
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bromfenac Ophthalmic Solution 0.06% n=38 Participants bromfenac ophthalmic solution 0.06% bilaterally twice a day
Age, Continuous	57.4 years STANDARD_DEVIATION 12.1 • n=93 Participants
Sex: Female, Male Female	28 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, Day 42

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

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.

Outcome measures

Outcome measures
Measure	Bromfenac Ophthalmic Solution 0.06% n=38 Participants bromfenac ophthalmic solution 0.06% bilaterally twice a day
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye	-0.65 score on a scale Standard Deviation 0.40

PRIMARY outcome

Timeframe: 52 days

Outcome measures

Outcome measures
Measure	Bromfenac Ophthalmic Solution 0.06% n=38 Participants bromfenac ophthalmic solution 0.06% bilaterally twice a day
Percentage of Participants With at Least One Adverse Event	9 Participants

SECONDARY outcome

Timeframe: Baseline, 42 days

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

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.

Outcome measures

Outcome measures
Measure	Bromfenac Ophthalmic Solution 0.06% n=38 Participants bromfenac ophthalmic solution 0.06% bilaterally twice a day
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye	-0.84 score on a scale Standard Deviation 0.75

Adverse Events

Bromfenac Ophthalmic Solution 0.06%

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bromfenac Ophthalmic Solution 0.06% n=38 participants at risk bromfenac ophthalmic solution 0.06% bilaterally twice a day
Infections and infestations Nasopharyngitis	5.3% 2/38 • 52 days

Additional Information

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER