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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:
ClinicalTrials.gov Identifier:
NCT01652664
First Posted: July 30, 2012
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652664


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01652664     History of Changes
Other Study ID Numbers: C-12-008
First Submitted: July 26, 2012
First Posted: July 30, 2012
Results First Submitted: March 31, 2015
Results First Posted: April 13, 2015
Last Update Posted: July 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Hydrophthalmos
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Travoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents