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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Glaucoma; Elevated IOP in Pediatric Patients; Ocular Hypertension in Pediatric Patients
• Intervention / Treatment: Drug: Travoprost 0.004% PQ ophthalmic solution; Drug: Travoprost Vehicle; Drug: Timolol, 0.5% or 0.25% ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Travoprost; Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months	Drug: Travoprost 0.004% PQ ophthalmic solution; Drug: Travoprost Vehicle; Inactive ingredients used to maintain masking
ACTIVE_COMPARATOR: Timolol; Timolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months	Drug: Timolol, 0.5% or 0.25% ophthalmic solution; Patients 2 months to < 3 years of age received 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in IOP at 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.	Baseline (Day 0), Month 3

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Subha Venkataraman, Clinical Project Lead, Alcon Research

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: July 27, 2012
• First Posted (ESTIMATE): July 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Glaucoma; Ocular Hypertension; Hydrophthalmos; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-12-008