A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension

A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution; Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Open-angle glaucoma or confirmed ocular hypertension.
• Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2.
• Sign an informed consent form.
• Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
• Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
• History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
• History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
• Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
• Severe central visual field loss in either eye.
• Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
• History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
• History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Travoprost/Timolol BAC-free; Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks	Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution
Active Comparator: Travoprost/Timolol; Travoprost 0.004%/Timolol 0.5% ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks	Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution; Other Names: DuoTrav®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure (IOP) combined across all visits and timepoints	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).	Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).	Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Pamela Smith, B.S., Alcon Research

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 2, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Hypertension; Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-07-64