Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)
Condition: Glaucoma; Ocular Hypertension; Open-Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost 0.004% ophthalmic solution; Bimatoprost 0.01% ophthalmic solution
Intervention MeSH terms: Bimatoprost; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular Hypertension; Open-Angle Glaucoma; Intraocular Pressure

Summary:

      The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs.
      bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with
      open-angle glaucoma or ocular hypertension after 6 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in at
             least one eye.

          -  Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic
             therapy or on the study medicine alone.

          -  Willing to discontinue the use of all other ocular hypotensive medications prior to
             receiving study medication and for the entire course of the study.

          -  Able to follow instructions, self instill study article, and attend all study visits.

          -  Best-corrected Snellen visual acuity of 20/200 or better in each eye.

          -  Sign Ethics Committee reviewed and approved informed consent form.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Known medical history of allergy, hypersensitivity or poor tolerance to any component
             of the preparations used in this study.

          -  Any abnormality preventing applanation tonometry in either eye.

          -  Dry eye previously or currently being treated with punctal plugs, punctal cautery,
             Restasis®, or topical ocular corticosteroids.

          -  Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
             eye.

          -  Intraocular conventional or laser surgery >3 months prior to consent.

          -  Risk of visual field or visual acuity worsening as a consequence of participation in
             the study, in the investigator's best judgment.

          -  Progressive retinal or optic nerve disease from any cause.

          -  Use of any systemic medications known to affect IOP which have not been on a stable
             course for at least 7 days prior to Screening or an anticipated change in dosage
             during the course of the study.

          -  Any clinically significant, serious, or severe medical condition.

          -  Women of childbearing potential who are pregnant, lactating, or not using reliable
             means of birth control.

          -  Participation in any other study within 30 days prior to Screening.

          -  Use of any systemic (oral), injectable or topical steroids.

          -  Other protocol-defined exclusion criteria may apply.