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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00637130

Collaborator

(none)

138

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma Ocular Hypertension	Drug: Travoprost ophthalmic solution, 0.0008% Drug: Travoprost ophthalmic solution, 0.001% Drug: Travoprost ophthalmic solution, 0.0012% Drug: TRAVATAN Other: Vehicle	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travoprost 0.0008% Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks	Drug: Travoprost ophthalmic solution, 0.0008%
Experimental: Travoprost 0.001% Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks	Drug: Travoprost ophthalmic solution, 0.001%
Experimental: Travoprost 0.0012% Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks	Drug: Travoprost ophthalmic solution, 0.0012%
Active Comparator: TRAVATAN + 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	Drug: TRAVATAN Other: Vehicle
Placebo Comparator: Vehicle Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks	Other: Vehicle

Outcome Measures

Primary Outcome Measures

Mean Intraocular Pressure [Up to 2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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