Dry Eye Syndrome
Conditions
Keywords
Sign and symptoms of dry eye disease
Brief summary
A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.
Interventions
DRUGBromfenac Ophthalmic Solution A
sterile ophthalmic solution
DRUGBromfenac Ophthalmic Solution B
sterile ophthalmic solution
DRUGPlacebo Comparator
sterile ophthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be of either gender and any race 18 years or older
Exclusion criteria
* Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ocular Surface Disease Index (OSDI) Total Score | 42 days | The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bromfenac Ophthalmic Solution 0.06% Bromfenac Ophthalmic Solution 0.06% twice a day | 141 |
| Bromfenac Ophthalmic Solution 0.03% Bromfenac Ophthalmic Solution 0.03% twice a day | 140 |
| Placebo Comparator Placebo Comparator
Placebo Comparator: sterile ophthalmic solution | 139 |
| Total | 420 |
Baseline characteristics
| Characteristic | Bromfenac Ophthalmic Solution 0.06% | Bromfenac Ophthalmic Solution 0.03% | Placebo Comparator | Total |
|---|---|---|---|---|
| Age, Continuous | 61.0 years | 61.6 years | 61.0 years | 61.2 years |
| Sex: Female, Male Female | 109 Participants | 112 Participants | 112 Participants | 333 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 27 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 0 / 140 | 0 / 139 |
| other Total, other adverse events | 9 / 141 | 8 / 140 | 7 / 139 |
| serious Total, serious adverse events | 2 / 141 | 3 / 140 | 1 / 139 |
Outcome results
Primary
Mean Ocular Surface Disease Index (OSDI) Total Score
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
Time frame: 42 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bromfenac Ophthalmic Solution 0.06% | Mean Ocular Surface Disease Index (OSDI) Total Score | 35.0 score on a scale | Standard Deviation 22.23 |
| Bromfenac Ophthalmic Solution 0.03% | Mean Ocular Surface Disease Index (OSDI) Total Score | 40.3 score on a scale | Standard Deviation 25.22 |
| Placebo Comparator | Mean Ocular Surface Disease Index (OSDI) Total Score | 36.9 score on a scale | Standard Deviation 23.24 |