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

Principal Investigator

Ta Chang

Clinical Trial ID

Institutional Protocol # 20120712
National Clinical Trials Identifier NCT01652664

Clinical Trial Summary


Phase

Phase 3


Funding Agency/Sponsor

Industry


Disease

Other


Enrollment Eligibility

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.


Contact Information

Study Contact Mariana Nunez
Phone Number 7863519110
Get detailed information on ClinicalTrials.Gov