Clinical trial NCT05763628: Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses
Official title: Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2023-03-10
Enrollment: 59
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.

Detailed description: This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) wear period.

Eligibility criteria: Inclusion Criteria:

1. Were at least 42 years of age and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Self-reported having had a full eye examination in the previous two years;
4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week
5. Were willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum

   * Maximum of 7 participants per site were habitual wearers of daily disposable lenses
   * Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal
   * Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL
   * Maximum of 3 habitual wearers per site of MyDay Multifocal
   * Maximum of 7 participants per site were habitual wearers of frequent replacement lenses
   * Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA
7. Had refractive astigmatism no higher than -0.75DC in each eye;
8. Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)

Exclusion Criteria:

A person was excluded from the study if they:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or interocular surgery.

Primary outcomes:
measure: Lens Handling for Removal
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vestal
country: United States
facility: Sacco Eye Group PLLC
state: New York
city: Athens
country: United States
facility: Athens Eye Care- Dr. Shane Foster & Associates
state: Ohio
city: Bellaire
country: United States
facility: Bellaire Family Eye Care
state: Texas
city: Toronto
country: Canada
facility: Eyes on Sheppard Clinic
state: Ontario
city: Toronto
country: Canada
facility: Spadina Optometry
state: Ontario
Study officials:
affiliation: Spadina Optometry
name: David Wilkinson
role: PRINCIPAL_INVESTIGATOR
affiliation: Bellaire Family Eye Care
name: Ashley Tucker
role: PRINCIPAL_INVESTIGATOR
affiliation: Eyes on Sheppard Clinic
name: Fiona Soong
role: PRINCIPAL_INVESTIGATOR
affiliation: Sacco Eye Group PLLC
name: Andrew Sacco
role: PRINCIPAL_INVESTIGATOR
affiliation: Athens Eye Care - Dr. Shane Foster & Associates
name: Shane Foster
role: PRINCIPAL_INVESTIGATOR
References: