Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient
Interventions
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
DRUGBimatoprost 0.015% formulation 1 ophthalmic solution
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
DRUGBimatoprost 0.015% formulation 2 ophthalmic solution
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
DRUGBimatoprost 0.02% ophthalmic solution
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs
Sponsors
Allergan
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
* Ocular hypertension or glaucoma in both eyes * Require IOP-lowering therapy in each eye
Exclusion criteria
* Uncontrolled systemic disease * Known allergy or hypersensitivity to bimatoprost
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure (IOP) | Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Patient Comfort | Days 1-4 |
| Patient Satisfaction | Day 5 |
| Treatment Preference | Day 5 |
Countries
United States
Outcome results
None listed