EUCTR2013-004302-26-PL进行中（未招募）1 期
A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Santen Oy
- 入组人数
- 18
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. Patient is a non-smoking male or female = 17 years of age on the day of signing the informed consent with the first day of study drug dosing to occur prior to the 18th birthday. Infants less than 12 months old must be of = 36 weeks gestational age and at least 1 month of age.
- •2. A diagnosis of primary or secondary paediatric glaucoma or ocular hypertension in one or both eyes.
- •3. A history of intraocular pressure (IOP) greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the prestudy visit.
- •4. Patient is currently prescribed ocular hypotensive medication or patient is treatmentnaïve.
- •5. Female patients of reproductive potential must demonstrate a negative pregnancy test at the prestudy visit.
- •6. Patient is judged to be in good health, other than having glaucoma or ocular hypertension, based on medical history, physical examination, vital signs measurements, and laboratory safety tests .
- •7. Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy visit.
- •8. Parent/legal guardian and/or patient have/has provided a written informed consent and patient assent has been given as applicable.
- •9. The patient and parent/guardian should agree to comply with study restrictions, treatment plan, procedures and keep scheduled clinic visits.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patient currently wears continuous wear contact lenses (use of daily wear contact lenses during the study is permitted).
- •2. Onesighted or monocular patients, including patients who cannot be dosed in both eyes for any reason.
- •3. History of goniotomy or trabeculotomy within 1 month of prestudy visit or history of cataract surgery, laser surgery, filtration surgery, implant surgery or cyclodestructive surgery within 3 months prior to prestudy visit in one or both eyes.
- •4. Patient has a history or evidence of significant ocular trauma within 3 months of prestudy visit.
- •5. Patient has a history or evidence of recent ocular inflammation and/or infection within 1 month of prestudy visit.
- •6. Patient has chronic conjunctivitis, chronic keratitis or lacrimal deficiency.
- •7. Patient is pregnant, breastfeeding, expecting to conceive within the projected duration of the study.
- •8. Patient has had major (nonocular) surgery, loss of > 5 cc/kg of blood within 4 weeks of the prestudy visit.
- •9. Any other ocular, systemic or psychiatric disease/condition or laboratory abnormality that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator.
- •10. History of febrile illness within 5 days prior to start of study treatment.
- •11. Patient has a history of hypersensitivity to any component of tafluprost eye drops, or known severe or serious hypersensitivity to any prostaglandin analogue product (e.g. latanoprost).
- •12. Patient has a history of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription
- •(overthecounter) drugs or food.
- •13. There is any concern by the investigator regarding the safe participation of a patient in the study; or for any other reason the investigator considers the patient inappropriate for participation in the study.
- •14. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days from the prestudy visit.
研究者
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