Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Patients 2 mo to < 18 years of age at the time of screening.
2. Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
NOTE: Patients with conditions requiring chronic treatment
with glucocorticoids resulting in steroid induced glaucoma may
be enrolled.
3. A parent/legal guardian (if necessary, a legally authorized
representative) must provide informed consent that has been
approved by the Institutional Review Board/ Independent Ethics
Committee (IRB/IEC), and children must agree to sign an
approved assent form when applicable.
4. Must agree to comply with the requirements of the study and
must be accompanied by a parent/guardian.
5. Aphakic patients with contact lenses may be enrolled.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Females of childbearing potential are excluded from participation in the study, if they meet any of the conditions outlined in the protocol.
2. Patients with only 1 sighted eye or monocular patients (including patients who cannot be dosed in both eyes for any reason).
3. History of chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpes keratitis).
4. Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
5. Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
6. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
7. Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
8. Intraocular surgery within the past 30 days prior to the Screening Visit.
9. Any abnormality preventing reliable tonometry including history of penetrating keratoplasty.
10. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
11. Hypersensitivity to prostaglandin analogues or to any component of the study medications, including medication administered during study exams, in the opinion of the Investigator.
12. Less than 30 days before the Screening Visit of stable dosing regimen of any medications (excluding the IOPlowering treatments) or substances administered by any route and used on a chronic basis. The dosing regimen of these medications should not change during the study.
13. Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
14. Concurrent use of topical prostaglandin analogues during investigational product treatment period.
15. Children less than 5kg of body weight.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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