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: May 28, 2014
Last verified: May 2014
  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:


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 ]

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 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
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

Locations
United States, Texas
Contact the Alcon Call Center
Fort Worth, Texas, United States, 76134
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: May 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Travoprost
Ophthalmic Solutions
Pharmaceutical Solutions
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 August 28, 2014