Clinical trial NCT05805150: Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently
Official title: Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2023-04-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

Detailed description: This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.

Eligibility criteria: Inclusion Criteria:

* Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Self-reports having a full eye examination in the previous two years;
* Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
* Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears soft contact lenses, for the past 3 months minimum;

  1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
  2. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
* Has refractive astigmatism no higher than -0.75DC in each eye;
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active ocular disease and/or infection that contraindicates contact lens wear;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
* Has known sensitivity to the diagnostic sodium fluorescein used in the study;
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
* Has undergone refractive error surgery or intraocular surgery.

Primary outcomes:
measure: Lens Handling on Removal
timeFrame: Collected once on day 6 at the end of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
Study officials:
affiliation: Complete Eye Care of Medina
name: Gina Wesley
role: PRINCIPAL_INVESTIGATOR
affiliation: Nittany Eye Associates
name: Michael Cymbor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kannarr Eye Care
name: Shane Kannarr
role: PRINCIPAL_INVESTIGATOR
affiliation: West Bay Eye Associates
name: Stephen Montaquila
role: PRINCIPAL_INVESTIGATOR
References: