EUCTR2012-001640-22-ES
Active, not recruiting
Not Applicable
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
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paediatric glaucoma
- Sponsor
- Alcon Research Ltd
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
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-GBAlcon Research Ltd25
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
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