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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01652664
First received: July 26, 2012
Last updated: June 30, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Pediatric Glaucoma
Elevated IOP in Pediatric Patients
Ocular Hypertension in Pediatric Patients
Drug: Travoprost 0.004% PQ ophthalmic solution
Drug: Timolol, 0.5% or 0.25% ophthalmic solution
Drug: Travoprost Vehicle
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline in IOP at Month 3 [ Time Frame: Baseline (Day 0), Month 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 184
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Travoprost 0.004% PQ ophthalmic solution Drug: Travoprost Vehicle
Inactive ingredients used to maintain masking
Active Comparator: 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
Drug: Timolol, 0.5% or 0.25% ophthalmic solution
Patients 2 months to < 3 years of age received 0.25%

  Eligibility

Ages Eligible for Study:   2 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652664

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Subha Venkataraman, Clinical Project Lead Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01652664     History of Changes
Other Study ID Numbers: C-12-008
Study First Received: July 26, 2012
Results First Received: March 31, 2015
Last Updated: June 30, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ethics Commission
Singapore: Institutional Review Board
United Kingdom: Research Ethics Committee
Taiwan: Research Ethics Committee
Philippines: Ethics Committee
Spain: Ethics Committee
Saudi Arabia: Ethics Committee
Colombia: Ethics Committee
France: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Belgium: Institutional Review Board
Poland: Ethics Committee
Romania: Ethics Committee
Mexico: Ethics Committee

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Cloprostenol
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Travoprost
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 03, 2015