6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Dose Level A / Brinzolamide 1% ophthalmic suspension; Dose Level B / Brinzolamide 1% ophthalmic suspension; Dose Level C / Brinzolamide 1% ophthalmic suspension; Brinzolamide 1% ophthalmic suspension AZOPT®; Travoprost 0.004% ophthalmic solution TRAVATAN Z®; Travoprost solution vehicle; Brinzolamide suspension vehicle
Intervention description: Fixed combination; Fixed combination; Fixed combination; Inactive ingredients used for masking purposes; Inactive ingredients used for masking purposes
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions; Brinzolamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular; Hypertension; OAG; POAG; OHT

Summary:

      The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination
      (Trav/Brinz) administered twice daily as compared to each of its marketed components
      (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z®
      plus AZOPT® in lowering intraocular pressure (IOP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open-angle glaucoma (including open-angle glaucoma with
             pseudoexfoliation or pigment dispersion) or ocular hypertension;

          -  IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean
             IOP must not be >36 mmHg at any time point;

          -  Able to understand and sign an informed consent form;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Woman of childbearing potential who is currently pregnant, intends to become pregnant
             during the study period, breastfeeding, or not using adequate birth control methods to
             prevent pregnancy throughout the study;

          -  Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate
             washout schedule prior to the E1 Visit;

          -  Chronic, recurrent or severe inflammatory eye disease;

          -  Ocular trauma within the past 6 months prior to the Screening Visit;

          -  Ocular infection or ocular inflammation within the past 3 months prior to the
             Screening Visit;

          -  Clinically relevant or progressive retinal disease such as retinal degeneration,
             diabetic retinopathy, or retinal detachment;

          -  Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to
             approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);

          -  Other ocular pathology (including severe dry eye) that may, in the opinion of the
             Investigator, preclude the administration of a topical prostaglandin analogue or
             topical carbonic anhydrase inhibitor;

          -  Intraocular surgery within the past 6 months prior to the Screening Visit;

          -  Ocular laser surgery within the past 3 months prior to the Screening Visit;

          -  Any abnormality preventing reliable applanation tonometry;

          -  Any other conditions including severe illness which would make the subject, in the
             opinion of the Investigator, unsuitable for the study;

          -  History of hepatic or renal disease that would preclude the safe administration of a
             carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;

          -  Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide
             derivatives, or to any component of the study medications in the opinion of the
             Investigator;

          -  Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (> 1 g daily)
             salicylate therapy;

          -  Use of any additional topical or systemic ocular hypotensive medication during the
             study;

          -  Concurrent use of glucocorticoids administered by any route;

          -  Less than 30 days stable dosing regimen before the Screening Visit of any medications
             (excluding the IOP-lowering treatments) or substances administered by any route and
             used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents);

          -  Therapy with another investigational agent within 30 days prior to the Screening
             Visit;

          -  Other protocol-specified exclusion criteria may apply.