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OpenTrials
Completed

NCT Number: NCT02003391

Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
  • Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
  • Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
  • Must be able to understand and sign an Informed Consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Use of medication excluded by the protocol.
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
  • Ocular surgeries or procedures excluded by the protocol.
  • Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
  • Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
  • Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Beta-blocker monotherapy

Drug

Per participant's current prescribed therapy

Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Drug

Other names: DUOTRAV®

Primary outcomes

  1. Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye

    Time frame: Week 4

    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.

Secondary outcomes

  1. Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye

    Time frame: Baseline (Day 0), Week 4

    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.

  2. Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye

    Time frame: Baseline (Day 0), Week 4

    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2013
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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