Completed
Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma
What is being tested
Travoprost 0.004% ophthalmic solution
+ Bimatoprost 0.01% ophthalmic solution
Drug
Who is being recruted
Eye Diseases
+ Glaucoma
+ Ocular Hypertension
Over 18 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: September 2012
Summary
Principal SponsorAlcon Research
Last updated: August 3, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.
Principal SponsorAlcon Research
Last updated: August 3, 2015
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
104 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 DiseasesGlaucomaOcular Hypertension
Criteria
7 inclusion criteria required to participate
Able to follow instructions and be willing and able to attend all study visits
Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period
Show More Criteria
12 exclusion criteria prevent from participating
Any abnormality preventing reliable applanation tonometry in either eye
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye
Contact lens wear
History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications)
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
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTravoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months
Group II
Active ComparatorBimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months
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