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

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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.


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.
We found this trial at
1
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Fort Worth, Texas 76134
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Fort Worth, TX
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