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

NCT01652664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2015-07-23

Study results available
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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

Interventions

DRUG

Travoprost 0.004% PQ ophthalmic solution

DRUG

Timolol, 0.5% or 0.25% ophthalmic solution

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

DRUG

Travoprost Vehicle

Inactive ingredients used to maintain masking

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Subha Venkataraman, Clinical Project Lead · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01652664 on ClinicalTrials.gov