An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults

Официальное название

A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects

Обзор

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

Подробное описание

Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation 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 formulation
• Препарат Vehicle
  Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation

Первичные конечные точки

• Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 [Срок оценки: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)]
• Change from baseline in investigator-assessed ocular redness at 600 minutes post-instillation on Day 1 [Срок оценки: Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1)]

Вторичные конечные точки (3)

• Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 [Срок оценки: Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)]
• Change from baseline in investigator-assessed ocular redness at 720 minutes post-instillation on Day 1 [Срок оценки: Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)]
• Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 [Срок оценки: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)]

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 ocular redness score greater than 1 unit on a 5-point scale in both eyes prior to randomization.
• Other protocol-defined inclusion criteria may apply.

Критерии исключения

• Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol.
• Ocular surgical interventions 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 parameters.
• Use of prohibited medications, devices, or treatments as specified in the 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: NCT07578363 · DEW261-C003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗