EUCTR2012-001640-22-BE
Active, not recruiting
Phase 1
An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients - Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
ConditionsPaediatric glaucomaTherapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]
DrugsTravatan
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Paediatric glaucoma
- Sponsor
- Alcon Research Ltd
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
Not specified
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