Back to resultsStudy of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Primary Purpose
Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost 0.004% PQ ophthalmic solution
Timolol, 0.5% or 0.25% ophthalmic solution
Travoprost Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Glaucoma
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost
Timolol
Arm Description
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
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
Outcomes
Primary Outcome Measures
Mean Change From Baseline in IOP at 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01652664
Brief Title
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost
Arm Type
Experimental
Arm Description
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
Arm Title
Timolol
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004% PQ ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Timolol, 0.5% or 0.25% ophthalmic solution
Intervention Description
Patients 2 months to < 3 years of age received 0.25%
Intervention Type
Drug
Intervention Name(s)
Travoprost Vehicle
Intervention Description
Inactive ingredients used to maintain masking
Primary Outcome Measure Information:
Title
Mean Change From Baseline in IOP at Month 3
Description
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.
Time Frame
Baseline (Day 0), Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subha Venkataraman, Clinical Project Lead
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
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