Clinical Performance of Verofilcon A Toric Contact Lenses

Официальное название

Clinical Performance of Verofilcon A Toric Contact Lenses in Satisfied Wearers of Senofilcon A Toric Contact Lenses With Blue Light Filtration

Обзор

The goal of this clinical trial is to \[primary purpose: is to determine if Total30 Multi focal toric conntact lensesare comfortable and the willigness for those who have previously worn reusable toric contact lenses are willing to stay in Total30 MFT after 1 month of wear during the duration of the study. Healthy previous reusable toric contact lens weareres will be refit into total30 MFT contact lenses and will be asked to gauge their comfort while wearing the lenses. Healthy adult participants who are presybyopic between the ages of 18-40 can participant, sex and gender are not disqualifiers unless the participant is pregnant or breast feeding. The main question\[s\] it aims to answer \[is/are\] \[primary hypothesis or outcome measure 1Proportions of toric CL wearers who have positive visual acuity scores in comfort and vision after one month of wear. \[primary hypothesis or outcome measure 2\]? Contact lens dry eye-8 scores will be less than 12 indicating high levels of comfort after one month of wear.

Подробное описание

TOTAL30® Multifocal Toric contact lenses (CLs) are a 1-month, silicone hydrogel (lehfilcon A), studies have likewise found the lehfilcon A material to provides a comfortable wearing experience for the full life of the CL and for the full CL wear day.1 While initial TOTAL30 data are promising, the literature currently lacks data directly related to the Total30 MFT design and a targeted study aimed at evaluating how Total30 MFT performs with regards to overall comfort, vision, and satisfaction for those who are previous reusable toric CL wearers and are now presbyopic. This transition could be particularly important for patients who are presbyopic and astigmatic given that these two patients groups tend to struggle more with CLs than spherical CL wearers. Thus, the purpose of this work is to determine Total30 MFT overall comfort, vision, willingness to remain in CLs after the study, and satisfaction for those who currently wear reusable silicone hydrogel toric CLs and are now presbyopic. These data will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting presbyopic patients who have astigmatism into Total30 MFT, especially after the onset of presbyopia.

Вмешательства

• Устройство Total 30 multi foric contact lenses
  Participants will be refit into total 30 contact lenses

Первичные конечные точки

• Visual acuity scores [Срок оценки: 1 month]

Вторичные конечные точки (2)

• Contact lens dry eye 8 questionnaire scores [Срок оценки: 1 month]
• Comfort VAS [Срок оценки: Day 1, Day 14 and day 29 text messages]

Критерии участия

Критерии включения

• Adults, ≥40-year-old, CL wearers with best-corrected 20/20 distance visual acuity or better.
• Requiring +0.75 ADD or more at standard near distance of 40 cm.
• Participants will be required to have worn reusable silicone hydrogel toric CLs in the past year and still at a minimum wearing the CLs occasionally without having significant discomfort or dryness.
• All participants will be required to have a CLDEQ-8 score <12.
• Participants will be required to be able to wear Total 30MFT CLs (presbyopic plus astigmatism both ≥0.75D OD and OS).
• Astigmatism ranging from 0.75 D to 2.50 D in each eye.
• Participants will be required to wear the study CLs for ≥13 hours each day with no overnight wear.
• Willing to wear study CLs for ≥16 hours on the Day 1 (1st full day), Day 14, and Day 29 when responses will be collected via text message.
• Participants will be willing to wear the CL every day of the week.
• Participants will be required to provide a glasses prescription that is less than 3 years old.
• Visual acuity with habitual reusable silicone hydrogel toric CLs is 20/25 or better in each eye.

Критерии исключения

• Have worn Total30 MFT in the past
• Are past rigid CL wearers
• Are currently wearing monovision CLs
• Have a history of being diagnosed with dry eye or ocular allergies
• Have known systemic health conditions that are thought to alter tear film physiology
• Have a history of viral eye disease
• Have a history of ocular surgery
• Have a history of severe ocular trauma
• Have a history of corneal dystrophies or degenerations
• Have active ocular infection or inflammation
• Are currently using isotretinoin-derivatives or ocular medications
• Are pregnant or breast feeding

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Southern College of Optometry — Memphis

Идентификаторы

NCT: NCT07586982 · IRB00006763-Total30MFT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗