Measuring Changes In Choroidal Thickness Induced By Prototype Soft Contact Lenses Worn For 1 Hour

Обзор

The objective of the study is to evaluate the short-term change in choroidal thickness induced by 3 prototype soft contact lenses for people with myopia.

Вмешательства

• Устройство Lens A
  Lens A of Study P/883/24/MO
• Устройство Lens B
  Lens B of Study P/883/24/MO
• Устройство Lens C
  Lens C of Study P/883/24/MO

Первичные конечные точки

• Change in Choroidal Thickness from Baseline to After 1 Hour of Contact Lens Wear [Срок оценки: After 1 hour of wearing each contact lens]

Критерии участия

Критерии включения

• Are 18-25 years of age (inclusive) and have full legal capacity to volunteer; Have read (or be read to) and signed the information and consent form; Habitually wear soft contact lenses or are spectacle wearers with previous experience of soft contact lens wear;
• Are myopic with both eyes having a vertex corrected spherical equivalent non-cycloplegic refraction of at least -0.50 DS and no more than -4.50 DS;
• Achieve at least LogMAR +0.10 with spherical equivalent refraction in each eye;
• Are willing and able to maintain the appointment schedule and follow the measurement visit instructions which include no use of caffeine drinks, alcohol or other stimulants 12 hours before each measurement visit and no smoking or use of recreational cannabis 24 hours before the study visit;
• Have not used a myopia control treatment within 2 years prior to Visit 0 (this includes multifocal spectacle or contact lens wear, orthokeratology, or atropine);
• Typically sleeps at least 7 hours per night.

Критерии исключения

• Participating in any concurrent clinical or research study;
• Have astigmatism of more than 1.00 DC in either eye as per non-cycloplegic refraction;
• Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
• Have any known active\* ocular disease and/or infection;
• Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism, and active allergies;
• Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include antihistamine, atropine eye drops;
• Have known sensitivity to the sodium fluorescein diagnostic pharmaceutical to be used in the study;
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
• Are an employee of the Centre for Ocular Research \& Education directly involved in this study (i.e. on the delegation log).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• Centre for Ocular Research and Education at the School of Optometry and Vision Science at — Waterloo

Идентификаторы

NCT: NCT07155551 · P/883/24/MO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗