Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Study Identifier
210961-002
CT.gov Identifier
NCT01110499
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 - Open Angle
    • Study Drug
  • AGN-210961 Formulation 1
  • AGN-210961 Formulation 2
  • AGN-210961 Formulation 3
  • AGN-210961 Formulation 4
  • AGN-210961 Formulation 5
  • AGN-210961 Formulation 6
  • AGN-210961 Formulation 7
  • bimatoprost ophthalmic solution 0.03%
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Ocular hypertension or primary open-angle glaucoma in each eye
    Exclusion Criteria:
    * Any active ocular disease * Anticipated wearing of contact lenses during study * Anticipated use of artificial tears during study * Contraindication to pupil dilatation

    Protocol Summary

    This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

    Study Locations

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