Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.

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Key information

Conditions

Pediatric Glaucoma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Elevated IOP in Pediatric Patients Eye Abnormalities Eye Diseases Glaucoma Glaucoma, Open-Angle Hydrophthalmos Infant, Newborn, Diseases Ocular Hypertension Ocular Hypertension in Pediatric Patients

Age range

2 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of pediatric glaucoma or ocular hypertension.
Qualifying mean IOP at the Eligibility Visit in at least one eye.
Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures.
History of chronic, recurrent or severe inflammatory eye disease.
Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
Clinically significant or progressive retinal disease.
Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker.
Intraocular surgery in the study eye within 30 days prior to the Screening Visit.
Any abnormality preventing reliable applanation tonometry.
Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Travoprost 0.004% PQ ophthalmic solution

Drug

Timolol, 0.5% or 0.25% ophthalmic solution

Drug

Patients 2 months to < 3 years of age received 0.25%

Travoprost Vehicle

Drug

Inactive ingredients used to maintain masking

Primary outcomes

Mean Change From Baseline in IOP at Month 3

Time frame: Baseline (Day 0), Month 3

IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jul 30, 2012
Registry last updated: Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed