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

Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Travoprost ophthalmic solution (new formulation); Drug: Travoprost ophthalmic solution, 0.004%; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Travoprost 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	Drug: Travoprost ophthalmic solution (new formulation)
Active Comparator: TRAVATAN; Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks	Drug: Travoprost ophthalmic solution, 0.004%; Other Names: TRAVATAN®; TRAVATAN Z®
Placebo Comparator: Vehicle; Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks	Drug: Vehicle; Inactive ingredients used as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in intraocular pressure (IOP)	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.	Baseline, Up to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intraocular pressure	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).	Baseline, Up to Week 4
Mean percent change from baseline in IOP	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.	Baseline, Up to Week 4

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Theresa Landry, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: April 29, 2008
• First Submitted That Met QC Criteria: April 30, 2008
• First Posted (Estimate): May 1, 2008

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Open-angle glaucoma; Ocular Hypertension; IOP
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-07-46