Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | Any - 17 |
Updated: | 3/1/2014 |
Start Date: | September 2012 |
End Date: | January 2014 |
Contact: | Alcon Call Center |
Phone: | 1-888-451-3937 |
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.
Travoprost ophthalmic solution, 0.004% (new formulation) is noninferior to Timolol
ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.
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.
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