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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 is currently recruiting participants.
Verified January 2013 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01652664
First received: July 26, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

The primary objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost ophthalmic solution, 0.004% (new formulation) is noninferior to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.


Condition Intervention Phase
Pediatric Glaucoma
Elevated Intraocular Pressure (IOP) in Pediatric Patients
 Drug: Travoprost ophthalmic solution, 0.004% (new formulation)
Drug: Timolol ophthalmic solution, 0.5%
 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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular pressure (IOP) change from baseline to Month 3 in the study eye. [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: September 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost
Travoprost ophthalmic solution 0.004% (new formulation), one drop administered in each eye once daily at 9 PM (± 30 minutes)
 Drug: Travoprost ophthalmic solution, 0.004% (new formulation)
Active Comparator: Timolol
Timolol ophthalmic solution, 0.5%, one drop administered in each eye twice daily at 9 AM (± 30 minutes) and 9 PM (± 30 minutes)
 Drug: Timolol ophthalmic solution, 0.5%
Timolol ophthalmic solution, 0.5%

  Eligibility

Ages Eligible for Study:   2 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 months to <18 years of age.
  • Diagnosis of pediatric glaucoma.
  • 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, are breast feeding, or are 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) in the opinion of the Investigator that would preclude the administration of a topical prostaglandin analog or a topical beta-blocker.
  • Intraocular surgery within the past 30 days in the study eye prior to the Screening Visit.
  • Any abnormality preventing reliable applanation tonometry.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652664

Contacts
Contact: Alcon Call Center 1-888-451-3937

Locations
United States, Texas
Contact the Alcon Call Center Recruiting
Fort Worth, Texas, United States, 76134
Contact: Alcon Call Center     888-451-3937        
Sponsors and Collaborators
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
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013