Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

NCT ID: NCT00763061

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-04-30

Brief Summary

To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Detailed Description

To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Conditions

Glaucoma

Study Design

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

Study Groups

Travoprost 0.004%

Travoprost 0.004%

Group Type: EXPERIMENTAL

Travoprost 0.004% Ophthalmic Solution (Travatan)

Intervention Type: DRUG

Travoprost at 9 AM + Placebo \& 9 PM

Timolol 0.5%

Timolol 0.5%

Group Type: ACTIVE_COMPARATOR

Timolol 0.5% Ophthalmic Solution (Timoptic)

Intervention Type: DRUG

Timolol in each eye, twice daily at 9 AM \& 9 PM

Interventions

Travoprost 0.004% Ophthalmic Solution (Travatan)

Travoprost at 9 AM + Placebo \& 9 PM

Intervention Type: DRUG

Timolol 0.5% Ophthalmic Solution (Timoptic)

Timolol in each eye, twice daily at 9 AM \& 9 PM

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ≥18 years;
• IOP=16-30mmHg
• OH or OAG with visual filed abnormality:

1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,

2. Glaucoma Hemifield Test outside normal limits,

3. Corrected Pattern Standard Deviation with p <5%

Exclusion Criteria

• Previous damage of anterior chamber angle;
• ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
• contact lens wearer;
• severe central field loss;
• uncontrolled cardiovascular, hepatic or renal disease;
• any medication within past 1 month.

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

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Alcon Research Ltd

Locations

Alcon Call Center

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

MS-06-02

Identifier Type: -

Identifier Source: org_study_id