A Randomized, Double-Masked, Vehicle-Controlled, Two-Period Crossover Study of Atropine Sulfate Ophthalmic Solution (0.005% w/v) for the Treatment of Symptoms of Epiphora
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 主要终点
- Change in tearing
研究概览
简要总结
This study tests whether a very low concentration of atropine eye drops (0.005%) reduces excessive tearing (epiphora) in adults. Each participant will use two different eye drops, one at a time: the atropine drop and an identical-looking drop with no active ingredient (vehicle). Each drop is used once nightly for 7 days, with about 2 weeks between the two treatment periods. Neither the participant nor the study doctor will know which drop is being used during each period. The main measure is the change in how often participants need to wipe their eyes because of tearing. About 12 to 18 adults will take part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Adults 18 years of age or older
- •Symptomatic epiphora (unilateral or bilateral) with tearing requiring eyelid wiping or dabbing at least 2 times per day (Munk score ≥2)
- •Epiphora attributed to functional/idiopathic, gustatory, environmental, or lacrimal outflow (e.g., nasolacrimal duct obstruction, punctal stenosis) etiology
- •Visual acuity of 20/200 or better in at least one eye (with habitual correction or pinhole)
- •Willing and able to self-administer eye drops nightly for 7 days in each of two treatment periods and attend all study visits
- •Prior use of topical atropine permitted if at least 10 days have elapsed since the last dose
排除标准
- •Clinically significant dry eye disease, or tearing judged to be a reflex response to ocular surface disease, blepharitis, or other ocular surface irritation
- •Regular use of artificial tears, ocular lubricants, or dry eye medications, or unwillingness to stop them during the study
- •Active or recent (within 30 days) ocular infection, or active dacryocystitis
- •Current use of ophthalmic anticholinergic agents (unless stopped at least 10 days before Visit 1)
- •Hypersensitivity to atropine, other anticholinergics, or any component of the formulation
- •Angle-closure glaucoma or narrow anterior chamber angles
- •Pregnancy or breastfeeding
- •Participation in another interventional study within 30 days
- •Any condition or medication that, in the investigator's judgment, would interfere with study assessments or subject safety
研究组 & 干预措施
Atropine then vehicle
Atropine then vehicle - Description: Atropine 0.005% nightly for 7 days, approximately 14-day washout, then vehicle nightly for 7 days.
干预措施: Atropine sulfate ophthalmic solution 0.005% (Drug)
Atropine then vehicle
Atropine then vehicle - Description: Atropine 0.005% nightly for 7 days, approximately 14-day washout, then vehicle nightly for 7 days.
干预措施: Vehicle arm (Drug)
Vehicle then atropine
Vehicle then atropine - Description: Vehicle nightly for 7 days, approximately 14-day washout, then atropine 0.005% nightly for 7 days.
干预措施: Atropine sulfate ophthalmic solution 0.005% (Drug)
Vehicle then atropine
Vehicle then atropine - Description: Vehicle nightly for 7 days, approximately 14-day washout, then atropine 0.005% nightly for 7 days.
干预措施: Vehicle arm (Drug)
结局指标
主要结局
Change in tearing
时间窗: Period baseline (Day 1) to Day 7 of each 7-day treatment period, assessed at the end-of-period visit (Day 8 ±2); approximately 4 weeks overall
Within-participant difference (atropine minus vehicle) in change in Munk epiphora score from period baseline to Day 7 of each treatment period. Munk score range 0-4; higher scores indicate more frequent tearing.
次要结局
未报告次要终点
研究者
Rehan Ahmed
Physician
Greater Houston Eye Consultants