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

Alcon

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution; Drug: Timolol Maleate Ophthalmic Solution 0.5%; Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN); Other: Timolol Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293787

C-04-03

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Travoprost 0.004%/Timolol 0.5%

Experimental group

Description:

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

Treatment:

Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution

Other: Timolol Vehicle

Xalatan + Timolol 0.5%

Active Comparator group

Description:

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

Treatment:

Drug: Timolol Maleate Ophthalmic Solution 0.5%

Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)