EUCTR2011-003278-10-FR进行中（未招募）1 期
A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With Glaucoma - Bimatoprost 0.03% Preservative-free Ophthalmic Solution in Paediatric Glaucoma
Allergan Ltd.0 个研究点目标入组 84 人开始时间: 2011年9月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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. Male or female patients, 2 months (age adjusted for prematurity, if applicable, for children younger than 1 year postnatal) to < 18 years of age at the baseline (day -1) visit (To adjust for prematurity, subtract the infant’s gestational age in weeks from 40 and then subtract this from the child’s postnatal age in weeks.)
- •2. Written parental/legal guardian consent and minor assent (if applicable) has been obtained in accordance with any applicable state and local laws/regulations. At IRB/IEC’s discretion, a minor’s oral assent my be obtained in lieu of a written assent.
- •3. Written documentation for use of health information has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Allergan’s Authorization for Use and Disclosure of Protected Health Information, or its equivalent, and Research Study Information [US sites] and written Data Protection consent [European Union sites]).
- •4. Good general health as determined by the investigator from medical history and physical examination
- •5. Patient has been diagnosed by an ophthalmologist to have congenital, juvenile, primary or secondary (except as excluded in Section 4.4 of the protocol), aphakic or pseudophakic glaucoma, requiring IOP lowering therapy in one or both eyes.
- •6. Based on the patient’s medical history and the investigator’s opinion, IOP is likely to be controlled for the next 12 weeks (after baseline) by a single IOP-lowering topical ophthalmic medication.
- •7. Patient can go without IOP-lowering therapy from 4 days to 2 weeks, without significant risk to the patient.
- •8. Ability of patient and/or parent(s)/legal guardian(s) to follow study instructions and willingness to complete all required procedures and visits
- •9. Baseline: Females of childbearing potential (ie, post-menarche) must have a urine pregnancy test result confirmed as negative prior to the start of treatment on day 1.
- •10. Baseline: For patients able to perform recognition acuity, a best corrected visual acuity score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic letter visual acuity chart, LEA symbol chart, or Allen pictures. For preverbal patients or patients who may be unable to be tested using standard methodology, patient must be able to at least fixate on and briefly follow an object
- •(eg, small toy, fix and follow”)
- •11. Baseline (morning): IOP = 22 mm Hg and = 36 mm Hg in one or both eyes
- •12. Baseline: Patient has been appropriately washed out of all IOP lowering medications in each eye.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 84
- •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. Uncontrolled systemic disease
- •2. Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, history of bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure or cardiogenic shock or uncontrolled congestive heart failure. Clearance for participation in the study from the patient’s primary paediatrician or primary care physician must be documented for all patients.
- •3. Clinically relevant low or high blood pressure or pulse rate for age as determined by the investigator
- •4. Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential not using a reliable means of contraception throughout the study
- •5. Abnormally low body weight for age (below 5th percentile)
- •6. Patients in whom surgical intervention is indicated or anticipated for IOP lowering within 12 weeks after baseline. Note: Patients with primary congenital glaucoma will be excluded from the study unless surgery has already been performed.
- •7. Patients with lens-induced glaucoma, steroid-induced glaucoma, or retinoblastoma
- •8. Patients with secondary angle closure glaucoma due to anatomical abnormalities
- •9. Patients with secondary glaucoma associated with increased episcleral pressure (eg, Sturge-Weber, cavernous fistula, orbital disease)
- •10. Any other active or recurrent ocular disease (eg, iritis, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies, diabetic retinopathy) in either eye that would interfere with the interpretation of the study data. However, ocular conditions of myopia, hyperopia, and strabismus (excluding cases where surgery is planned within the next 12 weeks) are allowed.
- •11. History or evidence of severe ocular trauma in either eye
- •12. Corneal or other ocular abnormalities (eg, bullous keratopathy, refractive surgery, corneal graft) that would preclude accurate readings with either Goldmann applanation tonometer or a hand-held tonometer. Note: A well-healed corneal scar or Haab’s striae will not exclude a patient.
- •13. Any ocular anterior segment (including glaucoma) surgery in the study eye(s) within 3 months prior to baseline
- •14. Patients who have had a cyclodestructive procedure
- •15. Known allergy or sensitivity to the study medication(s) or their components
- •16. Known allergy or contraindication to use of fluorescein
- •17. Contraindication to pupil dilation
- •18. Required chronic use of other ocular medications (post-screening visit) during the study. Note: Occasional use of artificial tear products is allowed but not within 24 hours prior to a scheduled visit through the week 12 visit.
- •19. Current enrollment in an investigational drug or device study or participation in such a study at or past the screening visit, or within 30 days prior to the baseline (day -1) visit
- •20. For patients with visual field test records, visual field loss that in the opinion of the investigator is functionally significant, or evidence of progressive visual field loss within the year prior to baseline (day -1)
- •21. Patient’s IOP was previously uncontrolled on bimatoprost or timolol monotherapy
- •22. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days prior to baseline or anticipated use within 21 days prior to a postbaseline study visit through the week 12
- •23. Use of topical ophthalmic corticosteroids from 2 months prior to the
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