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

Study Identifier
207281-004
CT.gov Identifier
NCT01215786
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Glaucoma - Open Angle
  • Ocular Hypertension
    • Study Drug
  • AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)
  • timolol ophthalmic solution 0.5%
  • AGN-207281 vehicle ophthalmic solution (Placebo)
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Newport Beach, California, United States
    Status
    Not applicable