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

Pediatric Glaucoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652664
• Other study ID #: C-12-008
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2012
• Last updated: June 30, 2015
• Start date: September 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardGermany: Ethics CommissionSingapore: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeTaiwan: Research Ethics CommitteePhilippines: Ethics CommitteeSpain: Ethics CommitteeSaudi Arabia: Ethics CommitteeColombia: Ethics CommitteeFrance: Ethics CommitteePortugal: Ethics Committee for Clinical ResearchBelgium: Institutional Review BoardPoland: Ethics CommitteeRomania: Ethics CommitteeMexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Travoprost 0.004% PQ ophthalmic solution

• Timolol, 0.5% or 0.25% ophthalmic solution
Patients 2 months to < 3 years of age received 0.25%
• Travoprost Vehicle
Inactive ingredients used to maintain masking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No