Efficacy of Changing to TRAVATAN® From Prior Therapy
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost 0.004% BAK-free
Intervention description: Containing Polyquad (PQ) preservative
Intervention MeSH terms: Travoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Open-angle glaucoma; Ocular hypertension; Hypertension; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Travoprost; Antihypertensive Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions

Summary:

      The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution
      without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic
      solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to
      tolerability issues.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;

          -  On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing
             generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a
             switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the
             investigator;

          -  Intraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on
             latanoprost ophthalmic solution 0.005% monotherapy;

          -  IOP considered to be safe (in the opinion of the investigator), in both eyes, in such
             a way that assured clinical stability of vision and the optic nerve throughout the
             study period;

          -  Willing to discontinue the use of all other ocular hypotensive medications 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 Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each
             eye;

          -  Must sign an 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 to be used in this study deemed clinically significant in the
             opinion of the Principal Investigator;

          -  Any abnormality preventing reliable applanation tonometry in either eye;

          -  Corneal dystrophies in either eye;

          -  Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
             eye;

          -  Any clinically significant, serious, or severe medical condition;

          -  Use of any systemic medications known to affect IOP which have not been on a stable
             course for at least 7 days prior to the Screening Visit or an anticipated change in
             the dosage during the course of the study;

          -  Severe dry eye or keratoconjunctivitis sicca which has been or is currently being
             treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular
             corticosteroids;

          -  Intraocular conventional surgery or laser surgery in either eye less than 3 months
             prior to the Screening Visit;

          -  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;

          -  Women who are pregnant, lactating, or not using reliable means of birth control;

          -  Other protocol-defined exclusion criteria may apply.