Clinical trial NCT03519919: Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study
Official title: Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 51
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.


Eligibility criteria: Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had a self-reported oculo-visual examination in the last two years.
* Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
* Presently wears lenses for minimum wear 4 days/week and 10 hours/day
* Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
* Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
* Current refraction indicates a reading addition of +1.50 or higher
* Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
* Spends 10 hrs or more indoors at least 5 days/week
* Possesses a smartphone and is willing to download the MetricWire app to receive

Exclusion Criteria:

* Is presently wearing Clariti 1 day multifocal lenses
* Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/or infection;
* 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 a study outcome variable;
* Has known sensitivity to fluorescein dye or products to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
* Is aphakic;
* Has undergone refractive error surgery;
* Is an employee of the Centre for Contact Lens Research

Primary outcomes:
measure: Vision Clarity During the Day - Distance Vision
timeFrame: Baseline
measure: Vision Clarity During the Day - Distance Vision
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of Participants With Lens Centration
timeFrame: Baseline
measure: Number of Participants With Lens Centration
timeFrame: 3 weeks
measure: Visual Acuity
timeFrame: Baseline
measure: Visual Acuity
timeFrame: 3 weeks
measure: Post-blink Lens Movement
timeFrame: Baseline
measure: Post-blink Lens Movement
timeFrame: 3 weeks
measure: Corneal Staining
timeFrame: Baseline
measure: Corneal Staining
timeFrame: 3 weeks
measure: Conjunctival Staining
timeFrame: Baseline
measure: Conjunctival Staining
timeFrame: 3 weeks
measure: Bulbar Hyperemia
timeFrame: Baseline
measure: Bulbar Hyperemia
timeFrame: 3 weeks
measure: Subjective Vision Satisfaction - Driving at Night
timeFrame: Baseline
measure: Subjective Vision Satisfaction - Driving at Night
timeFrame: 3 weeks
measure: Subjective Vision Satisfaction - Long Intermediate Vision
timeFrame: Baseline
measure: Subjective Vision Satisfaction - Long Intermediate Vision
timeFrame: 3 weeks
measure: Subjective Vision Satisfaction - Short Intermediate Tasks
timeFrame: Baseline
measure: Subjective Vision Satisfaction - Short Intermediate Tasks
timeFrame: 3 weeks
measure: Subjective Vision Satisfaction - Near Vision
timeFrame: Baseline
measure: Subjective Vision Satisfaction - Near Vision
timeFrame: 3 weeks
measure: Ease of Insertion
timeFrame: Baseline
measure: Ease of Insertion
timeFrame: 3 weeks
measure: Ease of Removal
timeFrame: Baseline
measure: Ease of Removal
timeFrame: 3 weeks
measure: Overall Satisfaction With Speed of Changing Focus
timeFrame: Baseline
measure: Overall Satisfaction With Speed of Changing Focus
timeFrame: 3 weeks
measure: Overall Satisfaction Preference Between Study and Habitual Contact Lenses
timeFrame: Baseline
measure: Overall Satisfaction Preference Between Study and Habitual Contact Lenses
timeFrame: 3 weeks
measure: Overall Comfort
timeFrame: 3 weeks
measure: Overall Preference Between Study and Habitual Contact Lenses for Lifestyle
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
References: