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

• ClinicalTrials.gov Identifier: NCT01652664
• Recruitment Status: Completed
• First Posted: July 30, 2012
• Results First Posted: April 13, 2015
• Last Update Posted: July 23, 2015
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief 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.

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 184 participants
• 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
• Study Start Date: September 2012
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
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%

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• 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

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
• Other Study ID Numbers: C-12-008
• First Posted: July 30, 2012
• 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; Timolol; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents