Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

NCT ID: NCT02003391

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-05-31

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DuoTrav

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

Group Type: EXPERIMENTAL

Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Beta-blocker monotherapy

Intervention Type: DRUG

Per participant's current prescribed therapy

Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Intervention Type: DRUG

Interventions

Beta-blocker monotherapy

Per participant's current prescribed therapy

Intervention Type: DRUG

Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

DUOTRAV®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Project Lead GCRA, Pharma

Role: STUDY_DIRECTOR

Alcon Research

References

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.

Reference Type: DERIVED

PMID: 28239491 (View on PubMed)

Other Identifiers

M-13-038

Identifier Type: -

Identifier Source: org_study_id