Pharmacokinetic and Safety Study of Travoprost 0.004% in PediatricGlaucoma Patients

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Patients < 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 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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