Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Identifier
GMA-LUM-09-014
CT.gov Identifier
NCT01253902
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
  • bimatoprost ophthalmic solution 0.01%
  • travoprost ophthalmic solution 0.004%
  • latanoprost ophthalmic solution 0.005%
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication * Best corrected visual acuity score of 20/100 or better in both eyes * Females on birth control pills must be on same type of pill and dose for at least 3 month
    Exclusion Criteria:
    * Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months * History of or active ocular infection/inflammation (eg, uveitis) * Punctal plug use * Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable) * Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months * History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s) * Planned contact lens wear during study

    Protocol Summary

    This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.

    Study Locations

    Location
    Status
    Location
    Rogers, Arkansas, United States
    Status
    Not applicable
    Location
    Calgary, Alberta, Canada
    Status
    Not applicable