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

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Travoprost 0.004% Ophthalmic Solution (Travatan); Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)

• Registration Number: NCT00763061
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Results First Submitted: 2009-04-28
• Results First Submitted QC: 2009-12-21
• Results First Posted: 2010-01-26
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-23
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost 0.004%	Travoprost 0.004% Ophthalmic Solution (Travatan)	Travoprost 0.004%
Timolol 0.5%	Timolol 0.5% Ophthalmic Solution (Timoptic)	Timolol 0.5%

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) at 9 AM	At Week 12 - At the 9 AM time point for the patient's worse eye.	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Week 12 - Mean IOP At 4 PM	At the 4 PM time point for the patient's worse eye.	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Secondary Outcome Measures

Name	Time	Method
Mean IOP Change From Baseline at 9 AM	Baseline to Week 12 - at 9 AM	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Mean IOP Change at 4 PM	Baseline to Week 12 - at 4 PM	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Trial Locations

Locations (1)

Alcon Call Center; 🇺🇸 Fort Worth, Texas, United States