Vision Satisfaction in Bright Light Clinical Trial
Official title:
ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
| NCT number | NCT04116736 |
| Other study ID # | CR-6334 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 19, 2019 |
| Est. completion date | March 10, 2023 |
| Verified date | March 2023 |
| Source | Johnson & Johnson Vision Care, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.
| Status | Completed |
| Enrollment | 146 |
| Est. completion date | March 10, 2023 |
| Est. primary completion date | March 10, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Potential subjects must satisfy all of the following criteria to be enrolled in the study: - Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses. - A minimum age of 18 years, with no maximum age. - The registrant must read and sign the Informed Consent form. - The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: - Potential subjects who meet any of the following criteria will be excluded from participating in the study: - Current participant in another research study. - Employee or relative of site, or family member of Recruiting Practitioner or Johnson & Johnson. - Non-spherical contact lens wearers, i.e. toric or multifocal lenses. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Optica Ronda | Almeria | |
| Spain | Natural Optics Balaguer | Balaguer | |
| Spain | Sanchez Rubal Ltd - Finisterre | La Coruna | |
| Spain | Sanchez Rubal Ltd. - Sanchez Bregua | La Coruna | |
| Spain | Centro Optico Raga | Linares | |
| Spain | Centro Boston de Optometria | Madrid | |
| Spain | Centro Optico Montero | Madrid | |
| Spain | Cirugia Ocular de Madrid | Madrid | |
| Spain | Opticalia Real Villa | Madrid | |
| Spain | Opticas ClaraVision | Ontinyent | |
| Spain | Centro Optico | Sevilla | |
| United Kingdom | Chalmers Opticians Ltd | Cardiff | Wales |
| United Kingdom | First Contact Opticians Ltd. | Eastcote | Middlesex |
| United Kingdom | Auckland Opticians | Horbury | Wakefield |
| United Kingdom | Urquhart Opticians Ltd | Kilmarnock | Scotland |
| United Kingdom | Eyes On the Common Ltd. | London | England |
| United Kingdom | Hodd Barnes Dickens Ltd | London | England |
| United Kingdom | P Shah Opticians | London | England |
| United Kingdom | Leightons Insight Marlow | Marlow | Buckinghamshire |
| United Kingdom | Eyesite Opticians | Reading | Berkshire |
| United Kingdom | Eyesite Opticians | Weybridge | Surrey |
| United Kingdom | Eyesite Opticians | Winchester | Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| Johnson & Johnson Vision Care, Inc. |
Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vision Satisfaction in Bright Lighting | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I was satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree). | up to 12-month follow-up | |
| Secondary | Overall quality of vision | This will be assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item uses a 5-point agreement scale (1: Strongly Disagree to 5: Strongly Agree). | up to 12-month follow-up | |
| Secondary | Pulfrich Effect | This will be assessed subjectively using the item "While wearing these lenses, my depth perception of moving objects has NOT been impacted". Subjects who disagree or strongly disagree with the statement will be considered to have experienced the Pulfrich effect. | up to 12-month follow-up | |
| Secondary | Overall comfort | This will be assessed using the item "How would you rate the overall comfort of these contact lenses?". The item uses the 5-point satisfaction scale, 1: Excellent, 2: Very Good, 3: Good, 4:
Fair and 5: Poor. |
up to 12-month follow-up | |
| Secondary | Reported serious and significant ocular adverse events | Incidence rate serious and significant ocular adverse events during the study period will be calculated (in 100 patient-year) using all available data from the entire study. | up to 12-month follow-up |