Clinical trial NCT05805059: Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses
Official title: Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses
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: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
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 contact lenses.

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

Eligibility criteria: Inclusion Criteria:

1. Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self-reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. 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.
7. Has refractive astigmatism no higher than -0.75DC in each eye;
8. 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:

1. Is participating in any concurrent clinical or research study;
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. 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: Ocoee
country: United States
facility: Coan Eye Care
state: Florida
city: Vestal
country: United States
facility: Sacco Eye Group, PLLC
state: New York
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Waterloo
country: Canada
facility: Insight Eye Care
state: Ontario
Study officials:
affiliation: Sacco Eye Group, PLLC
name: Andrew Sacco
role: PRINCIPAL_INVESTIGATOR
affiliation: Insight Eye Care
name: Carolyn MacNeil
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCare Vision Center
name: Katherine Bickle
role: PRINCIPAL_INVESTIGATOR
affiliation: Coan Eye Care
name: Roxanne Achong-Coan
role: PRINCIPAL_INVESTIGATOR
References: