Clinical trial NCT04116736: ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
Official title: ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision Satisfaction in Bright Light
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-07
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study subjects will be recruited from the clinical site's subject database and/or utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials. Within the sites, subjects that have received a prescription of either Intervention within the last 2 months will be invited to participate without regard to any demographic or other ocular features.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
timeFrame: 2-week questionnaire follow-up
measure: Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
timeFrame: 4-month questionnaire follow-up
measure: Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
timeFrame: 12-month questionnaire follow-up
Secondary outcomes:
measure: Overall Quality of Vision - 2-Week Questionnaire
timeFrame: 2-week questionnaire follow-up
measure: Overall Quality of Vision - 4-Month Questionnaire
timeFrame: 4-month questionnaire follow-up
measure: Overall Quality of Vision - 12-Month Questionnaire
timeFrame: 12-month questionnaire follow-up
measure: Overall Comfort - 2-Week Questionnaire
timeFrame: 2-week questionnaire follow-up
measure: Overall Comfort - 4-Month Questionnaire
timeFrame: 4-month questionnaire follow-up
measure: Overall Comfort - 12-Month Questionnaire
timeFrame: 12-month questionnaire follow-up
measure: Pulfrich Effect
timeFrame: 2-week, 4-month, and 12-month questionnaire follow-up
measure: Serious or Significant Adverse Events
timeFrame: Throughout the duration of the study, up to 12 months
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Optica Ronda
city: Balaguer
country: Spain
facility: Natural Optics Balaguer
city: La Coruna
country: Spain
facility: Sanchez Rubal Ltd. - Sanchez Bregua
city: La Coruna
country: Spain
facility: Sanchez Rubal Ltd - Finisterre
city: Linares
country: Spain
facility: Centro Optico Raga
city: Madrid
country: Spain
facility: Centro Optico Montero
city: Madrid
country: Spain
facility: Centro Boston de Optometria
city: Madrid
country: Spain
facility: Cirugia Ocular de Madrid
city: Madrid
country: Spain
facility: Opticalia Real Villa
city: Ontinyent
country: Spain
facility: Opticas ClaraVision
city: Sevilla
country: Spain
facility: Centro Optico
city: Reading
country: United Kingdom
facility: Eyesite Opticians
state: Berkshire
city: Marlow
country: United Kingdom
facility: Leightons Insight Marlow
state: Buckinghamshire
city: London
country: United Kingdom
facility: P Shah Opticians
state: England
city: London
country: United Kingdom
facility: Eyes On the Common Ltd.
state: England
city: London
country: United Kingdom
facility: Hodd Barnes Dickens Ltd
state: England
city: Winchester
country: United Kingdom
facility: Eyesite Opticians
state: Hampshire
city: Eastcote
country: United Kingdom
facility: First Contact Opticians Ltd.
state: Middlesex
city: Kilmarnock
country: United Kingdom
facility: Urquhart Opticians Ltd
state: Scotland
city: Weybridge
country: United Kingdom
facility: Eyesite Opticians
state: Surrey
city: Horbury
country: United Kingdom
facility: Auckland Opticians
state: Wakefield
city: Cardiff
country: United Kingdom
facility: Chalmers Opticians Ltd
state: Wales
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc Clinical Trial
role: STUDY_DIRECTOR
References: