Dry Eye Disease
Conditions
Brief summary
Efficacy study of ecabet ophthalmic solution in dry eye disease
Interventions
DRUGecabet ophthalmic solution
sterile ophthalmic solution
DRUGplacebo
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
* Diagnosed with dry eye disease
Exclusion criteria
* Dry eye disease secondary to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | 43 days | The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ecabet Ophthalmic Solution ecabet ophthalmic solution
ecabet ophthalmic solution: sterile ophthalmic solution | 95 |
| Vehicle Placebo comparator
placebo: sterile ophthalmic solution | 88 |
| Total | 183 |
Baseline characteristics
| Characteristic | Ecabet Ophthalmic Solution | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 13.2 | 56.0 years STANDARD_DEVIATION 15.2 | 56.0 years STANDARD_DEVIATION 14.2 |
| Sex: Female, Male Female | 76 Participants | 63 Participants | 139 Participants |
| Sex: Female, Male Male | 19 Participants | 25 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 88 |
| serious Total, serious adverse events | 1 / 95 | 0 / 88 |
Outcome results
Primary
Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test
The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.
Time frame: 43 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ecabet Ophthalmic Solution | Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | Anesthetized | 3.02 mm | Standard Deviation 4.7 |
| Ecabet Ophthalmic Solution | Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | Unanesthetized | 2.35 mm | Standard Deviation 5.53 |
| Vehicle | Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | Anesthetized | 2.15 mm | Standard Deviation 4.4 |
| Vehicle | Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test | Unanesthetized | 1.35 mm | Standard Deviation 5.38 |