Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults

Официальное название

A Two-Arm Multicenter Clinical Trial to Investigate Efficacy and Safety of FID123472 Ophthalmic Solution Compared With Vehicle in Adult Subjects With Ocular Redness

Обзор

The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.

Подробное описание

Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.

Вмешательства

• Препарат Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
  Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation
• Препарат Vehicle
  Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation

Первичные конечные точки

• Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) [Срок оценки: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)]
• Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3) [Срок оценки: Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)]

Вторичные конечные точки (2)

• Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) [Срок оценки: Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)]
• Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3) [Срок оценки: Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2)]

Критерии участия

Критерии включения

• Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form.
• Willing and able to follow all instructions and attend all study visits.
• History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
• Baseline investigator-assessed ocular redness score of greater than 1 on a 5-point scale in both eyes prior to randomization on Day 1 (Visit 2).
• Other protocol-defined inclusion criteria may apply.

Критерии исключения

• Known contraindications or sensitivity to the use of any of the investigational product(s) or their components, or any other medication required by the protocol.
• Ocular surgical intervention within 6 months prior to Visit 1 or during the study.
• Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study specific parameters.
• Use of any of the prohibited medications or devices as specified in the study protocol.
• Out-of-range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
• Abnormal intraocular pressure.
• 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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Contact Alcon Call Center for Trial Locations — Fort Worth

Идентификаторы

NCT: NCT07531043 · DEW261-C002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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