Clinical trial NCT06232590: Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types
Official title: Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types
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: 2024-01-31
Enrollment: 60
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: To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Detailed description: This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) 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 spherical multifocal soft contact lenses, for the past 3 months minimum:

   * Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
   * Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
   * Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
7. Had refractive astigmatism no higher than -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
9. Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).

Exclusion Criteria:

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 or ocular 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 affect contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein 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 intraocular surgery.

Primary outcomes:
measure: Lens Handling for Insertion
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: New Bremen
country: United States
facility: New Bremen EyeCare
state: Ohio
city: Toronto
country: Canada
facility: Spadina Optometry
state: Ontario
Study officials:
affiliation: Sacco Eye Group
name: Andrew Sacco
role: PRINCIPAL_INVESTIGATOR
affiliation: Spadina Optometry
name: David Wilkinson
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCare Vision Center
name: Katherine Bickle
role: PRINCIPAL_INVESTIGATOR
affiliation: New Bremen EyeCare
name: Dustin Gardner
role: PRINCIPAL_INVESTIGATOR
affiliation: Complete Eye Care of Medina
name: Gina Wesley
role: PRINCIPAL_INVESTIGATOR
References: