Completed
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
What is being tested
Travoprost ophthalmic solution (new formulation)
+ Travoprost ophthalmic solution, 0.004%
+ Vehicle
Drug
Who is being recruted
Eye Diseases+1
+ Glaucoma
+ Glaucoma, Open-Angle
Over 18 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: April 2008
Summary
Principal SponsorAlcon Research
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2008
Actual date on which the first participant was enrolled.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.
Official TitleComparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Principal SponsorAlcon Research
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
158 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Eye DiseasesGlaucomaGlaucoma, Open-AngleOcular Hypertension
Criteria
5 inclusion criteria required to participate
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;
Show More Criteria
11 exclusion criteria prevent from participating
Severe central visual field loss in either eye;
Chronic, recurrent or severe inflammatory eye disease;
Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
Any form of glaucoma other than open-angle glaucoma;
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalTravoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Group II
Active ComparatorTravoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Group III
PlaceboInactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers