A Long-term Safety Study of Once-daily Travatan

Phase 3

Completed

• Conditions: Glaucoma, Open-angle; Ocular Hypertension
• Interventions: Drug: Travatan

• Registration Number: NCT00051168
• Lead Sponsor: Alcon Research

Brief Summary

Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-01-03
• Study First Submitted QC: 2003-01-06
• Study First Posted: 2003-01-07
• Study Start: 2006-01
• Primary Completion: 2009-03
• Results First Submitted: 2010-03-22
• Results First Submitted QC: 2010-03-22
• Status Verified: 2010-04
• Results First Posted: 2010-04-12
• Last Update Submitted: 2011-10-02
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Travatan	Travatan	Travoprost (0.004%)

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure	At 5 years.	Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken.; All IOP measurements were performed with a Goldmann applanation tonometer.

Trial Locations

Locations (1)

Europe; 🇺🇸 Fort Worth, Texas, United States