Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution; Drug: Beta-blocker monotherapy

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DuoTrav; Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks.	Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution; Other Names: DUOTRAV®
Active Comparator: Beta-blocker; Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks.	Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution; Other Names: DUOTRAV®; Drug: Beta-blocker monotherapy; Per participant's current prescribed therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye	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.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye	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.	Baseline (Day 0), Week 4
Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye	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.	Baseline (Day 0), Week 4

Collaborators and Investigators

• Sponsor: Alcon Research

Publications and helpful links

General Publications

• Lerner SF, Park KH, Hubatsch DA, Erichev V, Paczka JA, Roberts TV. Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy. J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): August 8, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Ocular Hypertension; Open Angle Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Timolol; Ophthalmic Solutions; Travoprost; Adrenergic beta-Antagonists
• Other Study ID Numbers: M-13-038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No