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

Alcon

Status and phase

Completed

Phase 3

Conditions

Ocular Hypertension in Pediatric Patients

Pediatric Glaucoma

Elevated IOP in Pediatric Patients

Treatments

Drug: Travoprost 0.004% PQ ophthalmic solution

Drug: Travoprost Vehicle

Drug: Timolol, 0.5% or 0.25% ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01652664

C-12-008

Details and patient eligibility

About

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.

Enrollment

184 patients

Sex

All

Ages

2 months to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

184 participants in 2 patient groups

Travoprost

Experimental group

Description:

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

Treatment:

Drug: Travoprost 0.004% PQ ophthalmic solution

Drug: Travoprost Vehicle

Timolol

Active Comparator group

Description:

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

Treatment:

Drug: Timolol, 0.5% or 0.25% ophthalmic solution