Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops

Официальное название

Evaluation of the Safety and Effectiveness of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops in Subjects With Dry Eye Disease

Обзор

The purpose of this post-market clinical follow-up (PMCF) study is to describe the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II lubricant eye drops in subjects experiencing dry eye (DE) symptoms.

Подробное описание

Each subject's participation will last approximately 30 days and include three scheduled visits: a screening/baseline clinic visit on Day 1 (Visit 1), a telephone follow-up visit on Day 15 (-2/+5 days) (Visit 2), and an in-office visit on Day 30 (-2/+5 days) (Visit 3).

This study will be conducted in Canada.

Вмешательства

• Другое Tears Naturale Free lubricating eye drops
  Commercially available, preservative free, artificial tear product containing dextran 70 and hypromellose. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film.
• Другое Tears Naturale II lubricating eye drops
  Commercially available, artificial tear product containing dextran 70 and hypromellose with a gentle preservative for multi-dose use. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film.

Первичные конечные точки

• Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score [Срок оценки: Screening/Baseline Visit (Day 1), Day 30]

Критерии участия

Критерии включения

• Able to read, understand, and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form in English or French.
• Able to attend all study visits as required as per protocol.
• Mild to moderate dry eye disease.
• Willing to discontinue use of all habitual artificial tear supplements and use only the study device for the entire study duration.
• Other protocol-defined inclusion criteria may apply.

Критерии исключения

• Any known allergic reactions to the study products or its ingredients.
• Ocular injury to either eye in the past 3 months prior to screening.
• Ocular surgery within the previous 6 months or ocular surgery planned during the study.
• Use of any systemic medication known to cause dry eye for less than 1 month before the Screening/Baseline visit.
• Other protocol-defined exclusion criteria may apply.

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

Открытое

Основная цель

Лечение

Центры проведения

Канада · 6 центров

• Integra Eyecare Centre — Burnaby
• The Medical Arts Health Research Group — Kelowna
• Eyes on Sheppard — North York
• Dr. Shalu Pal & Associates — Toronto
• Institut de L'Oeil des Laurentides — Boisbriand
• Hopital de Chicoutimi and LASIK MD — Chicoutimi

Идентификаторы

NCT: NCT07540884 · LCC222-I001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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