Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%

Официальное название

Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%

Обзор

The aim of the trial is to compare the safety and efficacy of the moisturizing solution DROP 0.4% with the moisturizing solution AVIZOR EYE DROPS 0.2% PRESERVED in relieving the symptoms of dry eye over one month of use.

Вмешательства

• Устройство Multidose mosturizing solution DROP 0.4%
  Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
• Устройство Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
  Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes

Первичные конечные точки

• Changes in eye dryness symptoms [Срок оценки: 1 month]
• Changes in eye dryness symptoms [Срок оценки: 1 month]
• Changes in best corrected visual acuity (safety outcome) [Срок оценки: 1 month]
• Ocular and peri orbital adverse events [Срок оценки: 1 month]
• Serious adverse events [Срок оценки: 1 month]

Вторичные конечные точки (5)

• Stability of the tear film [Срок оценки: 1 month]
• Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse)) [Срок оценки: 1 month]
• Tear evaporation [Срок оценки: 1 month]
• Number of instillations per product [Срок оценки: 1 month]
• User satisfaction with the product [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Male or female, aged 18 years or older, capable of freely providing informed consent for participation in the study.
• Signed informed consent form prior to any study-related tests.
• Signed data protection form prior to any study-related tests.

Additionally, for Group 1 (Non contact lens users)

• Ocular surface disease index (OSDI) ≥ 13
• No use of contact lenses in the past month and not planning to use them during the study period.

Additionally, for Group 2 (contact lens users)

• Contact lens dry eye questionnaire (CLDEQ-8) ≥ 12
• Contact lens (CL) use with a habitual minimum use of 4 days per week and 4 hours per day in the past month.

Критерии исключения

• Any active ocular surface disease except for dry eye disease.
• Severe dry eye, defined as meeting at least one of the following criteria in at least one eye:

• Corneal fluorescein staining ≥ 4 on the Oxford scale (0-5).
• Conjunctival lissamine green staining ≥ 4 on the Oxford scale (0-5).
• Schirmer test value ≤ 2 mm.
• Tear stability (BUT) of 0 seconds.
• History of ocular surgery in the last 3 months or refractive corneal surgery in the last 6 months.
• History of herpetic keratitis or uveitis.
• History of severe ocular infections or inflammation in the 6 months prior to the study.
• History of allergies affecting the ocular surface during the study period.
• Patients who have started or are expected to modify the use of the following topical medications during the study (except for artificial tears/moisturizing and lubricating solutions):

• Calcineurin inhibitors (cyclosporine, tacrolimus, etc.) in the 12 weeks prior to the study.
• Corticosteroids or non steroid anti-inflammatory drugs (NSAID) in the 4 weeks prior to the study.
• Blood-derived treatments (autologous serum, enriched plasma, etc.), insulin, or amniotic preparations in the week prior to the study.
• Use of systemic medication with potential effects on the tear film that has been started or modified in the last month or is expected to change during the study.
• Known sensitivity or intolerance to any of the products used in the study.
• Subjects with clinically relevant or uncontrolled systemic diseases in the last 3 months that may interfere with study assessments or outcomes.
• Pregnancy or breastfeeding. Lack of effective contraceptive methods in women of childbearing potential.
• Participation in a clinical trial within the last 30 days.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06985875 · IOBA-Avizor 001-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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