Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

NCT02003391 | Completed Phase 4 Results

• 1 other identifier: M-13-038
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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

Keywords

Open Angle Glaucoma; Ocular Hypertension; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline (Day 0), Week 4

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

  Baseline (Day 0), Week 4

Study Arms (2)

DuoTrav

EXPERIMENTAL

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

Beta-blocker

ACTIVE COMPARATOR

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

Interventions

Beta-blocker monotherapy DRUG

Per participant's current prescribed therapy

Beta-blocker

Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution DRUG

Also known as: DUOTRAV®

Beta-blocker; DuoTrav

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• 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.

  PMID: 28239491 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost; Timolol; Duotrav

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Global Brand Leader, Medical Affairs, Glaucoma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Project Lead GCRA, Pharma

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 8, 2016
• Results First Posted: August 8, 2016

Record last verified: 2016-06