Ocular Hypertension Clinical Trial
Verified date | July 2015 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Ocular hypertension or primary open-angle glaucoma in each eye - Requires IOP-lowering therapy in both eyes - Visual acuity score of 20/100 or better in each eye Exclusion Criteria: - Experienced significant weight change (over 10 pounds) within 60 days - History of alcohol or drug addiction - History of migraines or frequent headaches - Anticipated wearing of contact lenses during the study - Required chronic use of ocular medications during study - Eye surgery within 6 months - Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months - Use of oral, intramuscular, intravenous corticosteroids within 21 days - Use of ophthalmic corticosteroids within 2 months |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Day 14 | No |
Secondary | Mean Concentration of AGN-207281 in Plasma at Day 7 | Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | Day 7 | No |
Secondary | Mean Concentration of AGN-207281 in Plasma at Day 14 | Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | Day 14 | No |
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