Efficacy and Safety of Travoprost 0.004% Versus Tafluprost 0.0015% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
Condition: Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: Travoprost 0.004% ophthalmic solution (TRAVATAN); Tafluprost 0.0015% ophthalmic solution
Intervention description: One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration; One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Glaucoma; IOP; Travoprost

Summary:

      The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and
      Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when
      both medications are administered in the evening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An EC-reviewed and approved (for use in this study) informed consent form must be
             read, signed, and dated by the participating patient as well as signed and dated by
             the individual (Principal Investigator or other site personnel) obtaining the informed
             consent, before conducting the Screening Visit and prior to initiation of study
             procedures.

          -  Patients must be at least 21 years of age.

          -  Must be able to follow instructions and be willing and able to attend required study
             visits.

          -  Must have a clinical diagnosis of ocular hypertension or primary open-angle glaucoma
             in at least one eye (qualifying eye).

          -  Currently treated patients, in the investigator's judgment, should require a change in
             treatment for reasons of improved efficacy, tolerability or compliance.

          -  Must have IOP considered to be safe, in both eyes, in such a way that should assure
             clinical stability of vision and the optic nerve throughout the trial.

          -  Must have an intraocular pressure of > 21 mm Hg in at least one eye at 08:00 and > 19
             mm Hg in the same eye at 16:00, and < 35 mm Hg in both eyes at all diurnal time points
             at Visit 2.

          -  Must have best corrected visual acuity of 6/60 (20/200 Snellen) or better in each eye.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of other primary or secondary glaucomas not listed in inclusion criterion.

          -  Presence of extreme narrow angle with complete or partial closure in either eye, as
             measured by gonioscopy (occludable angles treated with a patent iridectomy are
             acceptable).

          -  Any abnormality preventing reliable applanation tonometry in qualifying eye(s).

          -  Any opacity or patient uncooperativeness that restricts adequate examination of the
             ocular fundus or anterior chamber of either eye.

          -  Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
             eye. Blepharitis or non-clinically significant conjunctival injection is allowed.

          -  Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three
             months prior to Visit 1.

          -  Risk of visual field or visual acuity worsening as a consequence of participation in
             the trial, in the investigator's best judgment.

          -  Progressive retinal or optic nerve disease from any cause apart from glaucoma.

          -  Women of childbearing potential not using reliable means of birth control, or pregnant
             or lactating females.

          -  Any clinically significant, serious, or severe medical or psychiatric condition.

          -  A condition, which in the opinion of the investigator, would interfere with optimal
             participation in the study, or which would present a special risk to the patient.

          -  Participation in any other investigational study within 30 days prior to Visit 2.

          -  Known medical history of allergy or sensitivity to any components of the preparations
             to be used in this trial that is deemed clinically significant in the opinion of the
             investigator.

          -  Use of 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 7 days prior to
             Visit 2 or an anticipated change in the dosage during the course of the study.

          -  Anticipated use of systemic corticosteroids, by any route except inhaled, for greater
             than two weeks during the trial.

          -  A history of, or at risk for uveitis or cystoid macular edema (CME).

          -  History of ocular herpes simplex.

          -  Unwillingness to accept the risk of iris, skin, or eyelash changes associated with
             prostaglandin therapy.

          -  Other protocol-defined exclusion criteria may apply.