Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease

Официальное название

Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation

Обзор

The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are: * Is BUFY01 non-inferior to SVS20 in terms of signs of DED? * Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED? Participants will be asked to: * Visit the trial site at 4 different timepoints * Use the allocated study treatment everyday until the end of the study (during 3 months) * Be examined by the investigator * Complete several questionnaires * Return unused study treatment. Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.

Вмешательства

• Устройство BUFY01 eye drops in single-dose containers
  1 to 2 drops in each eye, as often as needed
• Устройство SVS20 eye drops in single-dose containers
  1 to 2 drops in each eye, as often as needed

Первичные конечные точки

• Signs [Срок оценки: Day 28]

Вторичные конечные точки (1)

• Symptoms [Срок оценки: Day 28]

Критерии участия

Inclusion Criteria includes:

• At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;
• At least one eye with Oxford score ≥ 4 and ≤ 9;
• At least one objective sign of tear deficiency (in at least one eligible eye);
• Having a health insurance.

Exclusion Criteria includes:

• Wear of contact lenses starting within the last 2 months;
• Best-corrected visual acuity (BCVA) > 1.00;
• Severe DED with one of the listed conditions:
• Severe blepharitis;
• Seasonal allergy;
• Any issues of the ocular surface not related to DED;
• History of ocular trauma, infection or inflammation not related to DED;
• History of ocular surgery, including laser surgery;
• Unstable glaucoma;
• Use of artificial tears with preservative within the last 2 weeks;
• Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:
• Known hypersensitivity to any constituent of the study treatments;
• Pregnancy or breastfeeding;
• Participation in another clinical study within the last 90 days;
• Legally restricted autonomy, freedom of decision and action.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Hôpital des Quinze-Vingts — Paris
• CHU Saint-Etienne — Saint-Priest-en-Jarez

Идентификаторы

NCT: NCT05865379 · BUFY01-CT-2101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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