Dry Eye Disease
Conditions
Brief summary
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
Interventions
DRUGbromfenac ophthalmic solution 0.06%
bromfenac ophthalmic solution 0.06% bilaterally twice a day
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years of age or older
Exclusion criteria
* No active ocular conditions of disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Percentage of Participants With at Least One Adverse Event | 52 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bromfenac Ophthalmic Solution 0.06% bromfenac ophthalmic solution 0.06% bilaterally twice a day | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Bromfenac Ophthalmic Solution 0.06% |
|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 2 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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.
Time frame: Baseline, Day 42
Population: All participants enrolled were included in the analysis population, with last observation carried forward applied for missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bromfenac Ophthalmic Solution 0.06% | Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye | -0.65 score on a scale | Standard Deviation 0.4 |
Primary
Percentage of Participants With at Least One Adverse Event
Time frame: 52 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bromfenac Ophthalmic Solution 0.06% | Percentage of Participants With at Least One Adverse Event | 9 Participants |
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.
Time frame: Baseline, 42 days
Population: All participants enrolled were included in the analysis population, with last observation carried forward applied for missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bromfenac Ophthalmic Solution 0.06% | 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 |