NCT02688556已完成3 期
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 745
- 试验地点
- 3
- 主要终点
- Tear Production
研究概览
简要总结
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of dry eye syndrome (KCS) for a period of at least 6 months
- •Clinical diagnosis of bilateral KCS
- •Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
- •Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
- •Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.
排除标准
- •Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
- •Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
- •Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
- •Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
- •Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
- •Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
- •Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
- •History of herpes keratitis.
- •Corneal transplant
- •Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
- •Cataract surgery within 3 months prior to the Screening Visit.
研究组 & 干预措施
OTX-101 0.09%
Experimental
0.09% cyclosporine nanomicellar ophthalmic solution
干预措施: cyclosporine (Drug)
Vehicle
Placebo Comparator
vehicle of OTX-101
干预措施: vehicle of OTX-101 (Drug)
结局指标
主要结局
Tear Production
时间窗: Baseline and 12 weeks
Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score
次要结局
- Conjunctival Staining(Baseline and 12 weeks)
- Central Corneal Staining(Baseline and 12 weeks)
- Symptom Score(Baseline and 12 weeks)
研究者
研究点 (3)
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