Efficacy of Changing to DUOTRAV® From Prior Therapy
Condition: Open-Angle Glaucoma; Ocular Hypertension; Pigment Dispersion Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost 0.004%+Timolol 0.5% ophthalmic solution
Intervention description: Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)
Intervention MeSH terms: Timolol; Travoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-angle glaucoma; Ocular hypertension; Pigment dispersion glaucoma; Intraocular pressure

Summary:

      The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV®
      from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle
      glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma
             in at least one eye.

          -  Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either
             administered concomitantly or in a fixed combination) within 4 weeks prior to the
             screening visit.

          -  IOP considered to be safe (in the opinion of the investigator), in both eyes, to
             assure clinical stability of vision and the optic nerve throughout the study period.

          -  IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be
             designated as the study eye).

          -  Willing to discontinue the use of all other ocular hypotensive medication(s) prior to
             receiving the study medication for the entire course of the study.

          -  Able to follow instructions and willing and able to attend all study visits.

          -  Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each
             eye.

          -  Sign informed consent.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Known medical history of allergy, hypersensitivity or poor tolerance to any component
             of DuoTrav® that is deemed clinically significant in the opinion of the Principal
             Investigator.

          -  Corneal dystrophies in either eye.

          -  Risk of visual field or visual acuity worsening as a consequence of participation in
             the study, in the investigator's best judgment.

          -  Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or
             severe chronic obstructive pulmonary disease that would preclude the safe
             administration of a topical beta-blocker.

          -  History of severe allergic rhinitis.

          -  A condition, which in the opinion of the Principal Investigator, would interfere with
             optimal participation in the study, or which would present a special risk to the
             subject.

          -  Participation in any other investigational study within 30 days prior to the Screening
             Visit.

          -  Other protocol-defined exclusion criteria may apply.