Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

Study Identifier
210669-003
CT.gov Identifier
NCT00809848
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
  • Ocular Hypertension
  • Glaucoma - Other
    • Study Drug
  • AGN-210669 ophthalmic solution, 0.075%
  • AGN-210669 ophthalmic solution, 0.05%
  • AGN-210669 ophthalmic solution, 0.025%
  • bimatoprost ophthalmic solution 0.03%
  • AGN-210669 vehicle ophthalmic solution
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Ocular hypertension or primary open-angle glaucoma * Females of non-childbearing potential * Subject requires IOP-lowering therapy in both eyes * IOP ≥ 22 mm Hg and ≤ 34 mm Hg * Has a visual acuity score of 20/100 or better in each eye
    Exclusion Criteria:
    * Uncontrolled systemic disease * Active ocular disease * Alteration of existing chronic systemic medications * Known allergy or sensitivity to the study medications * Ophthalmic corticosteroids * Visual field loss which in the opinion of the investigator is functionally significant * History of ocular laser, intraocular surgery, or refractive surgery

    Protocol Summary

    The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

    Study Locations

    Location
    Status
    Location
    Artesia, California, United States
    Status
    Not applicable