Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

Phase 2

Completed

• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Interventions: Drug: Travoprost ophthalmic solution, 0.0008%; Drug: Travoprost ophthalmic solution, 0.001%; Drug: Travoprost ophthalmic solution, 0.0012%; Drug: TRAVATAN; Other: Vehicle

• Registration Number: NCT00637130
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-01
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-17
• Status Verified: 2012-12
• Disposition First Submitted: 2012-12-03
• Disposition First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-04
• Disposition First Posted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria

• Age related
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost 0.0008%	Travoprost ophthalmic solution, 0.0008%	Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Travoprost 0.001%	Travoprost ophthalmic solution, 0.001%	Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Travoprost 0.0012%	Travoprost ophthalmic solution, 0.0012%	Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
TRAVATAN + Vehicle	TRAVATAN	TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks
TRAVATAN + Vehicle	Vehicle	TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks
Vehicle	Vehicle	Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure	Up to 2 weeks

Trial Locations

Locations (1)

Contact Alcon Call Center at 1-888-451-3937; 🇺🇸 Fort Worth, Texas, United States