Phase 3
Completed N=152
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Glaucoma · Elevated IOP in Pediatric Patients · Ocular Hypertension in Pediatric Patients
Source: ClinicalTrials.gov NCT01652664 ↗
Enrolled (actual)
152
Serious AEs
0.6%
Results posted
Apr 2015
Primary outcomePrimary: Mean Change From Baseline in IOP at Month 3 — -5.4; -5.3 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in IOP at Month 3 |
-5.4; -5.3 | — |
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.
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. Informational only — not medical advice.