EUCTR2012-001640-22-ES进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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 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.
- •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, including medication administered during study exams, 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
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