EUCTR2011-000160-97-BE进行中（未招募）1 期
A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, 2 PARALLEL ARM, VEHICLE CONTROLLED, 6-MONTH PHASE III TRIAL WITH A 6 MONTH OPEN LABEL TREATMENT SAFETY FOLLOW-UP PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF CYCLOKAT® 1MG/ML (CICLOSPORIN/CYCLOSPORINE) EYE DROPS, EMULSION ADMINISTERED ONCE DAILY IN ADULT PATIENTS WITH SEVERE DRY EYE DISEASE (DED) - SANSIKA
OVAGALI Pharma S.A.0 个研究点目标入组 252 人开始时间: 2011年3月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 252
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, from 18 years of age.
- •2. Patients with persistent severe DED at the Screening and Baseline Visits
- •3. Patient must provide written informed consent.
- •4. Patient must be willing and able to undergo and return for scheduled study-related examinations.
- •5. The same eye (eligible eye) should fulfill all the above criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Dry eye disease resulting from the destruction of conjunctival goblet cells or scarring.
- •2. Any relevant ocular anomaly other than DED interfering with the ocular surface including trauma, post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history, etc.
- •3. Abnormal lid anatomy, abnormalities of the nasolachrymal drainage system or blinking function in either eye.
- •4. Anticipated use of temporary punctal plugs during the study. Patients with punctal plugs placed prior to screening are eligible for enrolment, however, punctual plugs must remain in place during the study.
- •5. Active herpes keratitis or history of ocular herpes.
- •6. Within the 90 days before the Screening Visit history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal).
- •7. History of non-infectious ocular inflammation not associated with dry eye (e.g. uveitis, scleritis, peripheral ulcerative keratitis).
- •8. Any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study. Patients taking BAK-free IOP lowering medications are eligible for study enrolment.
- •9. Patients with severe blepharitis and/or Meibomian Gland Disease (MGD). Patients enrolled with mild to moderate blepharitis and/or MGD should be treated as appropriate during the study.
- •10. Patients with active rosacea and/or progressive pterygium.
- •11. History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.
- •12. Contact lenses wear during the study.
- •13. Any prior refractive surgery (i.e., LASIK, LASEK, PRK, etc). These procedures are not allowed during the course of the study.
- •14. Ocular laser/surgery other than refractive surgery (including palpebral and cataract surgery) within 90 days before the study. Elective ocular laser/surgery is not allowed during the course of the study.
- •15. Best corrected distance visual acuity (BCDVA) score = +1.0 LogMAR (= 35 ETDRS letters, = 20/200 Snellen or = 0.1) in each eye.
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