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Идёт набор NCT07606625

Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment

Фаза IV С лечением Dry Eye Meibomian Gland Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Varenicline 0.03Mg/Spray Nasal Soln.
Кому может быть актуально
Состояния в реестре: Dry Eye, Meibomian Gland Dysfunction. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

The Impact of Varenicline Nasal Spray 0.03mg Dry Eye Treatment on Ocular Surface Health, Tear Film Stability, and Ocular Discomfort

Обзор

The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD).

Подробное описание

Dry eye disease is a common condition that occurs when eyes do not produce enough tears or when the quality of the tears is poor causing tears to evaporate quickly off the eye. This can lead to symptoms such as dryness, burning, irritation, and/or blurred vision. Meibomian gland dysfunction is the most common cause of evaporative dry eye disease. The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD). The nasal spray is FDA approved for the treatment of signs and symptoms of dry eye disease.

Вмешательства

  • Препарат Varenicline 0.03Mg/Spray Nasal Soln
    After meeting eligibility criteria and signing informed consent, participants will be dispensed a 3-month supply of varenicline 0.03mg/spray nasal solution. Participants will take the nasal spray home and spray once in each nostril twice daily for 3 months

Первичные конечные точки

  • Change in tear lipid layer thickness [Срок оценки: Measured at baseline, 1-month, and 3 months]
  • Change in tear thinning rate [Срок оценки: Measured at baseline, 1-month, and 3 months]
Вторичные конечные точки (4)
  • Change in Meibomian gland function [Срок оценки: Measured at baseline, 1-month, and 3 months]
  • Change in tear production rate [Срок оценки: Measured at baseline, 1-month, and 3 months]
  • Change in tear breakup time [Срок оценки: Measured at baseline, 1-month, and 3 months]
  • Change in Ocular Comfort [Срок оценки: Measured at baseline, 1-month, and 3 months]

Критерии участия

Критерии включения

  • Is 18 years of age and has full legal capacity to volunteer (no max age requirement)
  • Baseline Ocular Surface Disease Index (OSDI) >13
  • Has mild to moderate MGD
  • Has best corrected visual acuity of 20/40 or better
  • Has had an oculo-visual examination in the last two years
  • Is willing to continue other daily dry eye management regimen (e.g., warm compresses, and/or eyelid margin cleaning)
  • Is willing to discontinue other prescription medications for dry eye disease (DED) management
  • Is willing to stop any topical eye drops before all planned visits
  • Has read, understood, and completed the informed consent letter

Критерии исключения

  • Is participating in any other type of clinical or research study
  • Is currently pregnant, nursing, lactating, or planning a pregnancy
  • Is currently having >50% blockage of Meibomian glands in more than two eyelids or significant atrophy (i.e., severe MGD)
  • Is currently using any topical ocular medications
  • Has chronic or currently active sinus related problems
  • Has blepharitis > grade 1
  • Has active ocular infections
  • Has a condition or in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study
  • Has received Rx DED treatment within one week of enrollment
  • Has received any thermal or light-based DED treatment within 30 days of enrollment
  • Has significant corneal epithelial defects
  • Has abnormal eyelid anatomy
  • Has corneal neuropathic pain
  • Has chronic or recurrent epistaxis (nosebleeds), coagulation disorders, or other conditions that may have led to a clinically significant increased risk of bleeding
  • Has any intraocular surgery including trabeculectomy (MIGS, laser, or small incision glaucoma surgery allowed), extraocular surgery in either eye within 3 months, or refractive surgery within 12 months of enrollment
  • Has a known allergy to a product used in this study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • U.C. Berkeley Clinical Research Center — Berkeley

Идентификаторы

NCT: NCT07606625 · 15446-MCLin

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗