Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Overview

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Full Title of Study: “Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Interventions

  • Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination

Arms, Groups and Cohorts

  • Experimental: DuoTrav
    • Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
    • Time Frame: Baseline, up to 6 weeks
    • As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma; – Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye); – On a stable medication regimen for IOP reduction one week prior to the screening visit; – Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye; – Sign informed consent; – Other protocol-defined inclusion criteria may apply. Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®; – Any abnormality that would preclude the reliable performance of applanation tonometry in either eye; – Infection in either eye; – Conventional or laser intraocular surgery in either eye 3 months prior to screening visit; – Risk for visual field or visual acuity worsening, in the opinion of the investigator; – Women of childbearing potential; – Pregnant or lactating women; – Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant. – Participation in another clinical study within 30 days before the screening visit; – Other protocol-defined exclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Abayomi Ogundele, PharmD, Study Director, Alcon Research

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