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Набор скоро начнётся NCT07635849

Randomized Clinical Trial of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease

Фаза IV С лечением Dry Eye Disease (DED)

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: Carboxy methyl cellulose, Preservative free Carboxy methyl cellulose.
Кому может быть актуально
Состояния в реестре: Dry Eye Disease (DED). 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
Nepal
Следующий шаг
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Официальное название

Comparative Effectiveness of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease: A Randomized Clinical Trial

Обзор

Dry Eye Disease (DED) is a common, chronic ocular surface disorder characterized by tear film instability, ocular discomfort, and visual disturbance. Artificial tears are the first-line treatment for DED; however, many formulations contain preservatives such as benzalkonium chloride (BAK) and stabilized oxychloro complex (SOC) which may cause ocular surface toxicity with long-term use. Preservative-free artificial tears are considered safer alternatives, but comparative clinical evidence from Nepal is limited. This study aims to compare the clinical efficacy and safety of preservative-free versus preserved carboxymethylcellulose (CMC) artificial tears in patients with Dry Eye Disease. This will be a hospital-based, randomized, double-blinded controlled clinical trial conducted in the ophthalmology outpatient department of a tertiary care hospital in Nepal. A total of 80 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive either preservative-free CMC artificial tears or preserved CMC artificial tears for a duration of eight weeks. Participant, investigators, outcome assessors and data analysts will remain blinded to minimize assessment bias. Baseline assessments will include the Ocular Surface Disease Index (OSDI) questionnaire, Tear Film Break-Up Time (TBUT), Schirmer's test (without anesthesia), and corneal fluorescein staining. These outcomes will be reassessed at four and eight weeks. Safety and tolerability will be evaluated by documenting patient-reported adverse effects. Data will be analyzed using appropriate statistical methods, with a p-value of less than 0.05 considered statistically significant. The study is expected to demonstrate superior safety and improved ocular surface outcomes with preservative-free artificial tears compared to preserved formulations. Findings from this research will provide local evidence to guide rational prescribing practices and improve the management of Dry Eye Disease in Nepal.

Вмешательства

  • Препарат Carboxy methyl cellulose
    A total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preserved CMC artificial tears for a duration of eight weeks.
  • Препарат Preservative free Carboxy methyl cellulose
    A total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preservative-free CMC artificial tears for a duration of eight weeks.

Первичные конечные точки

  • Ocular Surface Disease Index (OSDI) Score [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Вторичные конечные точки (3)
  • Tear Film Break-Up Time (TBUT) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Schirmer's Test (without anesthesia) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Corneal Fluorescein Staining Score [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Clinical diagnosis of Dry Eye Disease (OSDI >13 and TBUT <10 seconds)
  • Willingness to provide written informed consent

Критерии исключения

  • Contact lens use
  • Active ocular infection or inflammation
  • History of ocular surgery within the past 6 months
  • Use of systemic immunosuppressive therapy

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
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Nepal · 1 центр
  • Pokhara Academy of Health Sciences — Pokhara

Идентификаторы

NCT: NCT07635849 · CTRL-DEDCMC-PRVFREE/WITHPRV

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗