An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Travoprost 0.004% ophthalmic solution; Bimatoprost 0.01% ophthalmic solution
Intervention description: Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative; Ophthalmic solution containing benzalkonium chloride (BAK)
Intervention MeSH terms: Bimatoprost; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular hypertension

Summary:

      The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular
      pressure (IOP) and ocular surface and inflammatory biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye
             and be treatment naïve to any glaucoma treatment.

          -  Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which
             would be the study eye.

          -  IOP considered to be safe (in the opinion of the investigator), in both eyes, in such
             a way that should assure clinical stability of vision and the optic nerve throughout
             the study period.

          -  Able to follow instructions and be willing and able to attend all study visits.

          -  Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each
             eye.

          -  Must read, sign, and date an Ethics Committee-approved informed consent form.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Known medical history of allergy, hypersensitivity or poor tolerance to any components
             of the study medications to be used in this study that is deemed clinically
             significant in the opinion of the Principal Investigator.

          -  Any abnormality preventing reliable applanation tonometry in either eye.

          -  Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
             eye.

          -  Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical
             ocular corticosteroids.

          -  History of ocular surface disease (dry eye) or current/prior use of dry eye
             medications (either over-the counter or prescription medications).

          -  Contact lens wear.

          -  Intraocular conventional surgery or laser surgery in either eye that is less than
             three months prior to the Screening Visit.

          -  Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic
             blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and
             calcium channel blockers), which have not been on a stable course for at least 7 days
             prior to Screening Visit or an anticipated change in the dosage during the course of
             the study.

          -  Women of childbearing potential not using reliable means of birth control, are
             pregnant, or lactating.

          -  Unwilling to risk the possibility of darkened iris or eyelash changes.

          -  Participation in any other investigational study within 30 days prior to the Screening
             Visit.

          -  Other protocol-defined exclusion criteria may apply.