Evaluation of a Novel Ocular Lubricating Eye Drop

Обзор

The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye. In Part 1, participant will receive 1 drop of ABR2 in one eye and through assessments over a 1-hour period. In Part 2, participant will use 1 drop of ABR2 at least two times a day for 28-day period (may use up to 4 times a day as needed) This is a single arm, open label study with no placebo or comparative arm.

Подробное описание

Part 1 has a total of 2 scheduled visits, including Screening and Treatment visit. Participants will attend Part 1 for a total of 3.0 hours.

Part 2 has a total of 6 scheduled visits, including the Screening, baseline \& dispense visit, day 3, 1-week, 2-week, and 4-week Follow Up. Participants will attend Part 2 for a total of 6.5 hours.

Вмешательства

• Препарат Part 2 ABR2 At least twice a day for 28 days
  Use ABR2 at least BID, up to QID for 28 days
• Препарат Part 1: ABR2 single dose in one eye
  Receive a single dose in one eye only

Первичные конечные точки

• Number of Adverse Events [Срок оценки: At the end of Part 1: 60 minutes after single drop monocular instillation and At the end of Part 2 (after 28 days of bilateral use)]

Критерии участия

Критерии включения

• Are at least 18 years of age and have capacity to volunteer
• Are able to read (Part 2 only);
• Have signed an information and consent letter;
• Are willing to follow instructions and maintain the appointment schedule;
• Are willing to refrain from contact lens wear throughout the study period;
• Have a best corrected visual acuity of +0.20 LogMAR or better in each eye;
• Have an OSDI score ≥13 AND at least one of the following signs in at least one eye: Non-invasive tear film break-up time (NITBUT) < 10 sec, AND/OR ocular surface staining (> 5 corneal spots, and/ or > 9 conjunctival spots)

Критерии исключения

• Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days;
• Have a known active ocular disease and/ or infection with the exception of dry eye disease;
• Have any slit lamp findings that would contraindicate use of the study product;
• Have a systemic condition that would contraindicate use of the study product;
• Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Have undergone refractive error surgery or intraocular surgery within the last 12 months;
• Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product;
• Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only);
• Are an employee of the Centre for Ocular Research \& Education directly involved in this study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Centre for Ocular Research & Education, School of Optometry & Vision Science, University o — Waterloo

Идентификаторы

NCT: NCT07593404 · PN251 · P/892/25/PL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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