Atropine Eye Drops for Watery Eyes (Excessive Tearing)

Официальное название

A Randomized, Double-Masked, Dose-Ranging Study of Atropine Sulfate Ophthalmic Solution for the Treatment of Symptoms of Epiphora

Обзор

The goal of this clinical trial is to learn if low-dose atropine eye drops work to reduce excessive watery eyes (epiphora) in adults. It will also learn about the safety of the eye drops. The main questions it aims to answer are: Do the eye drops reduce how often participants have watery eyes? What medical problems do participants have when taking the eye drops? Researchers will compare two strengths of the eye drops (0.005% and 0.01%) to see whether one works better than the other and whether the lower strength works as well as the higher one. Participants will: * Use the assigned eye drops in the affected eye(s) for one week * Visit the clinic twice for checkups and eye tests * Receive a follow-up phone call about two weeks after starting, to check on any symptoms

Вмешательства

• Препарат Atropine ophthalmic solution
  The interventions are two low doses of atropine ophthalmic solution

Первичные конечные точки

• Munk Score Change [Срок оценки: Time Frame: From enrollment to the end of treatment at 1 week]

Критерии участия

You may be able to join if you:

• Are 18 years or older
• Have vision of 20/200 or better in at least one eye
• Have watery eyes (epiphora) bad enough to need wiping or dabbing at least twice a day
• Have watering caused by a functional/idiopathic, gustatory ("crocodile tears"), environmentally triggered (reflex), or obstructive cause - in one or both eyes
• Have a healthy eye surface, with no significant dry eye, active eye infection, or active eye inflammation
• Have adequate eyelid position and tone, where surgery is not the main treatment needed and reducing tear production is likely to help
• Are willing and able to put drops in your eye(s) once each night for 7 days and attend the study visits
• Can understand and follow the study procedures and communicate with study staff (an interpreter is allowed)

You will not be able to join if you:

• Have significant dry eye disease
• Have had an active eye infection within the past 30 days
• Have an active tear-sac infection, or a blocked tear duct that needs urgent surgery (a blocked tear duct that does not need surgery is allowed)
• Currently use eye drops that affect tear production or eye-surface testing, unless you are willing to stop them for the study
• Are allergic to, or should not take, atropine, similar (anticholinergic) medicines, or any ingredient in the study drops
• Have narrow-angle or angle-closure glaucoma, where dilating the pupil would not be safe for you
• Are pregnant or breastfeeding
• Are taking part in another interventional study, or took part in one within 30 days before screening
• Have any condition that, in the doctor's judgment, would make it unsafe for you to join or hard to follow the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Greater Houston Eye Consultants — Houston
• North Texas Eye Specialists — Mesquite

Идентификаторы

NCT: NCT07676981 · IND-180375-P2-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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