Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Alcon

Status and phase: Completed; Phase 4

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Beta-blocker monotherapy; Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02003391

M-13-038

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

DuoTrav

Experimental group

Description:

Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks.

Treatment:

Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Beta-blocker

Active Comparator group

Description:

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.

Treatment:

Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Drug: Beta-blocker monotherapy