Clinical trial NCT04449263: Comparing the Performance of 1 Day Multifocal Contact Lenses
Official title: Comparing the Performance of 1 Day Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2020-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Detailed description: The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Eligibility criteria: Inclusion Criteria:

1. Is at least 42 years of age 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, 5 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
7. Has 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. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

Exclusion Criteria:

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

Primary outcomes:
measure: Subjective At-home Ratings for Ease of Lens Handling for Insertion
timeFrame: Day 13
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Poway Eyecare
state: California
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
Study officials:
affiliation: Golden Vision
name: Wayne Golden
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Poway Eyecare
name: Keith Wan
role: PRINCIPAL_INVESTIGATOR
affiliation: Kannarr Eye Care
name: Shane Kannarr
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Optometric Group
name: David Ardaya
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCare Vision Center
name: Katherine Bickle
role: PRINCIPAL_INVESTIGATOR
References: