Dispensing Study for the Phenacite Project
30 октября 2020 г. обновлено: CooperVision, Inc.
Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
Тип исследования
Интервенционный
Регистрация (Действительный)
25
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Indiana
-
Bloomington, Indiana, Соединенные Штаты, 47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 35 лет (Взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
- Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
- Has not worn lenses for at least 12 hours before the initial visit
- Has a subjective response at baseline, which indicates suitability for this study
- Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.
Exclusion Criteria:
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- Is aphakic
- Has anisometropia of >1.00
- Has undergone corneal refractive surgery
- Has strabismus
- Has any ocular amblyopia >= 1line of HC Visual Acuity
- Is participating in any other type of eye related clinical or research study
- Has participated in study CV-14-32.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
|
Активный компаратор: comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Subjective Ratings of Lens Comfort
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings of Lens Comfort
Временное ограничение: 2 Weeks
|
Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
|
2 Weeks
|
|
Over Refraction for Optimized Distance Acuity
Временное ограничение: 2 weeks
|
Over Refraction for optimized distance acuity measured using logMAR
|
2 weeks
|
|
Binocular Distance Visual Acuity - High Illumination High Contrast
Временное ограничение: Baseline (after 5 minutes of lens dispense)
|
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Distance Visual Acuity - High Illumination High Contrast
Временное ограничение: 2 weeks
|
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
Временное ограничение: Baseline (after 5 minutes of lens dispense)
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
Временное ограничение: 2 weeks
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
Временное ограничение: Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
Временное ограничение: 2 weeks
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
Временное ограничение: Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
Временное ограничение: 2 weeks
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Lens Fit - Post Blink Movement
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
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Baseline (after 15 minutes of lens dispense)
|
|
Lens Fit - Post Blink Movement
Временное ограничение: 2 weeks
|
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
|
2 weeks
|
|
Push - Up Test for Lens Tightness
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
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Baseline (after 15 minutes of lens dispense)
|
|
Push - Up Test for Lens Tightness
Временное ограничение: 2 weeks
|
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
|
2 weeks
|
|
Lens Mobility Rating
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
|
Baseline (after 15 minutes of lens dispense)
|
|
Lens Mobility Rating
Временное ограничение: 2 weeks
|
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
|
2 weeks
|
|
Overall Lens Fit Acceptance
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
|
Baseline (after 15 minutes of lens dispense)
|
|
Overall Lens Fit Acceptance
Временное ограничение: 2 weeks
|
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Distance Vision
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Distance Vision
Временное ограничение: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Near Vision
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Near Vision
Временное ограничение: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Computer Vision
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Computer Vision
Временное ограничение: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Overall Vision
Временное ограничение: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Overall Vision
Временное ограничение: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Corneal Staining Extent
Временное ограничение: 2 weeks
|
Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- >45% of area
|
2 weeks
|
|
Conjunctival Staining
Временное ограничение: 2 weeks
|
Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
|
2 weeks
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Pete Kollbaun, OD PhD, CORL Indiana University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 апреля 2015 г.
Первичное завершение (Действительный)
1 июля 2015 г.
Завершение исследования (Действительный)
1 июля 2015 г.
Даты регистрации исследования
Первый отправленный
1 мая 2015 г.
Впервые представлено, что соответствует критериям контроля качества
1 мая 2015 г.
Первый опубликованный (Оценивать)
6 мая 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 ноября 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
30 октября 2020 г.
Последняя проверка
1 октября 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CV-15-16
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .