A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

Обзор

13 weeks, open-label, daily disposable contact lens dispensing study.

Подробное описание

The purpose of this clinical study is to evaluate the safety and clinical performance of the investigational soft contact lens when worn in a daily wear modality, by assessing total suspended eye(s) as the primary variable.

Вмешательства

• Устройство Treatment
  Test lenses will be worn on a daily disposable basis for up to 13 weeks. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week.

Первичные конечные точки

• Total suspended eye(s) [Срок оценки: From enrollment to the end of treatment at 13 weeks]

Вторичные конечные точки (8)

• Tabulation of Discontinued Eye(s) [Срок оценки: From enrollment to the end of treatment at 13 weeks]
• Tabulation of Subjective Symptoms [Срок оценки: From enrollment to the end of treatment at 13 weeks]
• Tabulation of Slit-Lamp Microscopy Findings [Срок оценки: From enrollment to the end of treatment at 13 weeks]
• Tabulation of Adverse Event(s) [Срок оценки: From enrollment to the end of treatment at 13 weeks]
• Tabulation of Adverse Device Effect(s) [Срок оценки: From enrollment to the end of treatment at 13 weeks]
• Tabulation of Device Deficiencies [Срок оценки: From enrollment to the end of treatment at 13 weeks]
• Contact Lens Corrected Visual Acuity [Срок оценки: From enrollment to the end of treatment at 13 weeks]
• Mean of Contact Lens Corrected Visual Acuity [Срок оценки: From enrollment to the end of treatment at 13 weeks]

Критерии участия

Критерии включения

• Adult with an age ≥ 18;
• Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours per day within 3 months prior to study screening (by verbal confirmation);
• Participant must be stop wearing any contact lenses more than 7 days prior to screening;
• Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
• Astigmatism of 1.25D or less in both eyes;
• Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;
• Participant must be able to be successfully fit with study lenses;
• The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;
• The participant must read and sign the Informed Consent Form.

Критерии исключения

• Women who are currently pregnant;
• Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
• Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study enrollment for which contact lens wear could be contraindicated, as determined by the investigator;
• Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
• Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
• Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and/or refractive surgery during the study;
• Current or history of herpetic keratitis in either eye;
• Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;
• Current clinical finding of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye (defined as Schirmer test < 5 mm/5 min), recurrent corneal erosions, aphakia, or moderate or above corneal distortion;
• Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);
• Participation in any interventional clinical trial within 30 days prior to study enrollment;
• Any biomicroscopy findings at screening that are Grade 3 or higher and/or corneal neovascularization that is Grade 2 or higher and/or presence of corneal infiltrates;
• Any history of a contact lens-related corneal inflammatory or infectious event within 12 months prior to study enrollment that may contraindicate contact lens wear;
• Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
• Participants are considered ineligible for the study as judged by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 2 центра

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
• Linkou Chang Gung Memorial Hospital — Taoyuan

Публикации

• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 75th WMA General Assembly, Helsinki, Finland, October 2024.
• ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice.
• ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations.
• Chalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582. PMID 25574042
• Approaches to Clinical Evaluation of Standard Contact Lenses 標準的なコンタクトレンズの臨床評価に関する考え方 (Japan Independent Industry Guidelines 業界自主指針; August 1, 2009 平成21 年8 月1 日).

Идентификаторы

NCT: NCT07322211 · UNC-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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