Comparison of Ocular Lubricants in People With Symptoms of Dry Eye

Официальное название

Symptomology Changes With Systane PRO PF Versus Thealoz Duo

Обзор

Ocular dryness and discomfort are symptoms commonly associated with dry eye. Lubricating eye drops, also called artificial tears, are often used to moisten the eye and provide relief from these symptoms. There are currently several types of lubricating eye drops available, differing in their ingredients, consistency, and recommended frequency of application. The aim of this study is to compare the effectiveness of two lubricating eye drops that differ in their ingredients and recommended frequency of application. The goal is to see whether they perform the same or if one of them provides better relief for people with dry eye symptoms. One of the eye drops is commercially available in Canada, the other one is not commercially available in Canada and therefore considered an investigational eye drop. This eye drop is available in the United States of America. In this study, participants will use one drop twice per day and the other drop four times per day. Each product will be used for 4 weeks and all participants will use both products (one after the other). There will be a 2-week period of no drops between the two study products. Before starting each drop and after 4 weeks of drop use, we will assess the eyes of the participants and ask them how their eyes feel. Participants will also be asked to answer a series of questions regarding the drops. Participants will encounter procedures that they normally experience in an eye care setting. The results will help the funding company to better understand the performance of the products used in this study. It may also help eyecare practitioners in managing their patients with dry eye symptoms. The hypothesis is that the drop used twice a day will be non-inferior to the drop used 4 times per day for the change in dry eye symptoms (assessed with the Ocular Surface Disease Index questionnaire) after 4 weeks of use.

Вмешательства

• Препарат Propylene glycol 0.6%
  1 drop per eye multiple times per day for 4 weeks
• Устройство 3% trehalose and 0.15% sodium hyaluronate
  1 drop per eye multiple times per day for 4 weeks

Первичные конечные точки

• Difference Ocular Surface Disease Index (OSDI) Score between Baseline and 4 Weeks [Срок оценки: From baseline (dispense) to 4 weeks of ocular lubricant use]

Критерии участия

Критерии включения

• Are at least 18 years of age and have full legal capacity to volunteer;
• Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved informed consent form;
• Are willing and able to attend all study visits as required per protocol;
• Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration;
• Have dry eye symptomatology as per Tear Film \& Ocular Surface Society Dry Eye WorkShop (TFOS DEWS) II definition:

• Have an Ocular Surface Disease Index (OSDI) score ≥13;
• Have an absence of active\* anterior segment disease;
• Have not worn contact lenses for the previous 14 days before screening, and are willing to not wear contact lenses for the duration of the study;
• Are correctable to a visual acuity of +0.20 LogMAR or better (in at least one eye) with refraction results.

Критерии исключения

• Have taken part in an interventional clinical study within the previous 14 days before screening;
• Are participating in any concurrent ocular or interventional clinical trial;
• Have any active\* ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops);
• Started any systemic medication known to cause dry eye (e.g., anti-histamine, antidepressants, benzodiazepines, etc.) within 30 days before screening. Stable dosing for >30 days before screening is allowed, but changes (including commencing new) of dosing of such medication within the study period would lead to early exit from the study;
• Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated;
• Have biomicroscopy signs of grade 3 or more (Efron scale);
• Have known sensitivity to the diagnostic pharmaceuticals or to any ingredients in the study products;
• Are pregnant, lactating or planning a pregnancy at the time of enrolment;
• Are a member of the Centre for Ocular Research \& Education directly involved in this study (on the delegation log);
• Are an employee of Alcon.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Centre for Ocular Research & Education (CORE) — Waterloo

Идентификаторы

NCT: NCT07451184 · 47903 · 98631981

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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