Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis

Официальное название

A Phase 3 Randomized, Multi-Center, Placebo-Controlled, Masked Study to Evaluate the Clinical Efficacy and Safety of Fusidic Acid 1% Viscous Topical Antibiotic Eye Drops for the Treatment of Suspected Bacterial Conjunctivitis

Обзор

The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.

Вмешательства

• Препарат Fusidic Acid 1%
  Fusidic acid 1%
• Препарат Placebo
  Placebo ophthalmic solution

Первичные конечные точки

• Clinical Cure [Срок оценки: Visit 2 (Day 4)]

Вторичные конечные точки (3)

• Microbial Eradication [Срок оценки: Visit 2 (Day 4)]
• Microbial Eradication [Срок оценки: Visit 3 (Day 8)]
• Clinical Cure [Срок оценки: Visit 3 (Day 8)]

Критерии участия

Main Inclusion Criteria:

• Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye, confirmed by the presence of purulent or mucopurulent ocular discharge and a grade ≥ 1 on the modified Validated Bulbar Redness (VBR) conjunctival redness scale.
• Have not received any ocular treatment for conjunctivitis, aside from eyelid hygiene, ≤14 days prior to Visit 1.
• Have a negative viral conjunctivitis test in both eyes.
• Agree to discontinue use of eye/eyelid cosmetics during study participation.
• Agree to discontinue use of contact lenses during study participation.
• Be willing and able to provide informed consent and comply with the study requirements.
• Not be currently pregnant or breastfeeding. If sexually active, agree to use approved contraception for the duration of the study.

Main Exclusion Criteria:

• Have signs and/or symptoms or a diagnosis of fungal, protozoal, or viral etiology ≤30 days prior to Visit 1.
• Have experienced signs and symptoms of bacterial conjunctivitis for >48 hours prior to Visit 1.
• Require or are expected to require use of any non-study topical ocular medication or systemic medications prior to Visit 1 as specified in the protocol as ineligible.
• Have any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
• Have a known intolerance, sensitivity or allergy to the study medications or any of their components.
• Have participated in another clinical trial ≤30 days or received another experimental drug ≤90 days prior to Visit 1.
• Have a family member or household member enrolled in this study.
• Have a condition which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
• Be an employee of or immediate family member of an employee (directly related to study conduct) at the study site.

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

Лечение

Центры проведения

США · 38 центров

• Baxis Site 04 — Little Rock
• Baxis Site 24 — Huntington Beach
• Baxis Site 19 — La Jolla
• Baxis Site 39 — Long Beach
• Baxis Site 31 — Los Angeles
• Baxis Site 38 — Los Angeles
• Baxis Site 20 — Sherman Oaks
• Baxis Site 34 — Delray Beach
• … и ещё 30 центров

Идентификаторы

NCT: NCT06911424 · BXP-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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