EUCTR2012-001640-22-FR进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
Pharmacokinetic and Safety Study of Travoprost 0.004% in PediatricGlaucoma PatientsPaediatric glaucomaEUCTR2012-001640-22-GBAlcon Research Ltd25
进行中（未招募）
1 期
Pharmacokinetic and Safety Study of Travoprost 0.004% in PediatricGlaucoma PatientsPaediatric glaucomaEUCTR2012-001640-22-BEAlcon Research Ltd24
进行中（未招募）
不适用
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma PatientsPaediatric glaucomaEUCTR2012-001640-22-ESAlcon Research Ltd24
进行中（未招募）
1 期
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: 21CTIS2022-502547-36-00Amicus Therapeutics Inc.25
招募中
3 期
ATB200/AT2221 Phase 3 Open-label Study in Pediatric SubjectPompe diseaseJPRN-jRCT2031210014Wright Jacquelyn22