Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

Phase 2

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost ophthalmic solution, 0.004%; Drug: Vehicle; Drug: Travoprost ophthalmic solution (new formulation)

• Registration Number: NCT00670033
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-01
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2014-06
• Disposition First Submitted: 2014-07-09
• Disposition First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Disposition First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Satisfy all informed consent requirements;
• Diagnosed with open-angle glaucoma or ocular hypertension;
• Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
• IOP measurements in at least 1 eye as specified in protocol;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
• Any form of glaucoma other than open-angle glaucoma;
• Severe central visual field loss in either eye;
• Chronic, recurrent or severe inflammatory eye disease;
• Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
• Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
• Intraocular surgery within the past 6 months;
• Ocular laser surgery within the past 3 months;
• Any abnormality preventing reliable applanation tonometry;
• Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRAVATAN	Travoprost ophthalmic solution, 0.004%	Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Vehicle	Vehicle	Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Travoprost new formulation	Travoprost ophthalmic solution (new formulation)	Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in intraocular pressure (IOP)	Baseline, Up to Week 4	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

Secondary Outcome Measures

Name	Time	Method
Mean intraocular pressure	Baseline, Up to Week 4	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Mean percent change from baseline in IOP	Baseline, Up to Week 4	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.