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

NCT ID: NCT00293800

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-12-31

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution

Intervention Type: DRUG

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Timolol Vehicle

Intervention Type: OTHER

Placebo

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

Group Type: ACTIVE_COMPARATOR

Latanoprost 0.005% Ophthalmic Solution (XALATAN)

Intervention Type: DRUG

Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Timolol 0.5% Ophthalmic Solution

Intervention Type: DRUG

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Interventions

Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type: DRUG

Latanoprost 0.005% Ophthalmic Solution (XALATAN)

Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type: DRUG

Timolol 0.5% Ophthalmic Solution

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type: DRUG

Timolol Vehicle

Placebo

Intervention Type: OTHER

Other Intervention Names

XALATAN

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

C-04-04

Identifier Type: -

Identifier Source: org_study_id