EUCTR2012-001640-22-GB
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
- 25
- Status
- Active, not recruiting
- Last Updated
- 7 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
Similar Trials
Active, not recruiting
Phase 1
Pharmacokinetic and Safety Study of Travoprost 0.004% in PediatricGlaucoma PatientsEUCTR2012-001640-22-FRAlcon Research Ltd24
Active, not recruiting
Phase 1
Pharmacokinetic and Safety Study of Travoprost 0.004% in PediatricGlaucoma PatientsPaediatric glaucomaTherapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]EUCTR2012-001640-22-BEAlcon Research Ltd24
Active, not recruiting
Not Applicable
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma PatientsPaediatric glaucomaTherapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]EUCTR2012-001640-22-ESAlcon Research Ltd24
Active, not recruiting
Phase 1
Study to evaluate the safety and efficacy of Cipaglucosidase Alfa and Miglustat in pediatric subjects with late-onset Pompe diseaseate-onset Pompe diseaseMedDRA version: 20.0Level: SOCClassification code: 10010331Term: Congenital familial and genetic disorders Class: 21Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]CTIS2022-502547-36-00Amicus Therapeutics Inc.25
Recruiting
Phase 3
ATB200/AT2221 Phase 3 Open-label Study in Pediatric SubjectPompe diseaseJPRN-jRCT2031210014Wright Jacquelyn22