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

Phase 3

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN); Drug: Timolol Maleate Ophthalmic Solution 0.5%; Other: Timolol Vehicle

• Registration Number: NCT00293787
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-02-17
• Study First Submitted QC: 2006-02-17
• Study First Posted: 2006-02-20
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• 18 years or older.
• Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
• Mean IOP in each eye less than 18 mmHg at the screening visit.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Pregnant.
• History of chronic or recurrent severe inflammatory eye disease.
• Ocular trauma within the past six months in either eye.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xalatan + Timolol 0.5%	Timolol Maleate Ophthalmic Solution 0.5%	Timolol 0.5% in both eyes each morning at 8 a.m. and Xalatan in both eyes each evening at 8 p.m. for 3 months
Travoprost 0.004%/Timolol 0.5%	Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution	Travoprost 0.004%/Timolol 0.5% in both eyes each morning at 8 a.m. and Timolol vehicle in both eyes each evening at 8 p.m. for 3 months
Travoprost 0.004%/Timolol 0.5%	Timolol Vehicle	Travoprost 0.004%/Timolol 0.5% in both eyes each morning at 8 a.m. and Timolol vehicle in both eyes each evening at 8 p.m. for 3 months
Xalatan + Timolol 0.5%	Latanoprost 0.005% Ophthalmic Solution (XALATAN)	Timolol 0.5% in both eyes each morning at 8 a.m. and Xalatan in both eyes each evening at 8 p.m. for 3 months

Primary Outcome Measures

Name	Time	Method
Mean intraocular pressure (IOP) change at 3 months from baseline	3 months