Phase 3 N=152 Randomized Double-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01652664 ↗

Enrolled (actual)

152

Serious AEs

0.6%

Results posted

Apr 2015

Primary outcome: Primary: Mean Change From Baseline in IOP at Month 3 — -5.4; -5.3 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Travoprost 0.004% PQ ophthalmic solution (Drug); Timolol, 0.5% or 0.25% ophthalmic solution (Drug); Travoprost Vehicle (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in IOP at Month 3	-5.4; -5.3	—

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.

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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01652664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.