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 0.5% Ophthalmic Solution; Other: Timolol Vehicle

• Registration Number: NCT00293800
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-12
• Study Completion: 2005-12
• 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: 2012-02-11
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xalatan + Timolol 0.5%	Timolol 0.5% Ophthalmic Solution	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
Travoprost/Timolol	Timolol Vehicle	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
Travoprost/Timolol	Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution	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
Xalatan + Timolol 0.5%	Latanoprost 0.005% Ophthalmic Solution (XALATAN)	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

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline	3 months