A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Alcon Research1 site in 1 country87 target enrollmentJune 2008

ConditionsOpen-Angle Glaucoma Ocular Hypertension

InterventionsTravoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution Travoprost 0.004%/Timolol 0.5% ophthalmic solution

DrugsTravoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution Travoprost 0.004%/Timolol 0.5% ophthalmic solution

Overview

Phase: Phase 3
Intervention: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution
Conditions: Open-Angle Glaucoma
Sponsor: Alcon Research
Enrollment: 87
Locations: 1
Primary Endpoint: Mean Intraocular Pressure (IOP) combined across all visits and timepoints
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

December 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Open-angle glaucoma or confirmed ocular hypertension.
•Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 \& 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 \&
•Sign an informed consent form.
•Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
•Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

•Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
•Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
•History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
•History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
•Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
•Severe central visual field loss in either eye.
•Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
•History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
•History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
•Other protocol-defined exclusion criteria may apply.