A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution; Other: Timolol Vehicle; Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN); Drug: Timolol 0.5% Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older.
• Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
• Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Pregnant
• History of chronic or recurrent severe inflammatory eye disease.
• History of ocular infection or ocular inflammation within the past three months in either eye.
• 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Travoprost/Timolol; One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months	Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution; Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension; Other: Timolol Vehicle; Placebo
Active Comparator: Xalatan + Timolol 0.5%; One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months	Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN); Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension; Other Names: XALATAN; Drug: Timolol 0.5% Ophthalmic Solution; Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline	3 months

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: February 17, 2006
• First Submitted That Met QC Criteria: February 17, 2006
• First Posted (Estimate): February 20, 2006

Study Record Updates

• Last Update Posted (Estimate): February 14, 2012
• Last Update Submitted That Met QC Criteria: February 11, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: hypertension; glaucoma; ocular; Open-angle
• 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; Latanoprost
• Other Study ID Numbers: C-04-04