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

NCT ID: NCT01652664

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-03-31

Brief 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.

Conditions

Pediatric Glaucoma; Elevated IOP in Pediatric Patients; Ocular Hypertension in Pediatric Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Travoprost 0.004% PQ ophthalmic solution

Intervention Type: DRUG

Travoprost Vehicle

Intervention Type: DRUG

Inactive ingredients used to maintain masking

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

Group Type: ACTIVE_COMPARATOR

Timolol, 0.5% or 0.25% ophthalmic solution

Intervention Type: DRUG

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

Interventions

Travoprost 0.004% PQ ophthalmic solution

Intervention Type: DRUG

Timolol, 0.5% or 0.25% ophthalmic solution

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

Intervention Type: DRUG

Travoprost Vehicle

Inactive ingredients used to maintain masking

Intervention Type: DRUG

Eligibility 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.

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Subha Venkataraman, Clinical Project Lead

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-008

Identifier Type: -

Identifier Source: org_study_id