Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Phase 4

Completed

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

• Registration Number: NCT02003391
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-05-17
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Results First Posted: 2016-08-08
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta-blocker	Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution	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.
DuoTrav	Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution	Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks.
Beta-blocker	Beta-blocker monotherapy	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.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye	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 Outcome Measures

Name	Time	Method
Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye	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.
Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye	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.