Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow

Study Identifier
GMA-COM-08-009
CT.gov Identifier
NCT00811850
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Glaucoma - Other
    • Study Drug
  • fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
  • fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    30+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Age: 30 years or older. 2. Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye. 3. Best corrected visual acuity at least 20/40 in at least one eye.
    Exclusion Criteria:
    1. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy. 2. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis). 3. History or signs of intraocular trauma. 4. Any abnormality preventing reliable applanation tonometry. 5. Current use of any ophthalmic or systemic steroid which may interfere with this investigation. 6. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

    Protocol Summary

    A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.

    Study Locations

    Location
    Status
    Location
    Indianapolis, Indiana, United States
    Status
    Not applicable