Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) (Drug); timolol ophthalmic solution 0.5% (Drug); AGN-207281 vehicle ophthalmic solution (Placebo) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
Secondary outcome: Mean Concentration of AGN-207281 in Plasma at Day 7Mean Concentration of AGN-207281 in Plasma at Day 14
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Newport Beach, California, United States
Additional Information
Starting date: October 2010
Last updated: July 22, 2015
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