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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Timolol; Travoprost

Criteria

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.