Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study

Not Applicable

Completed

Conditions: Presbyopia

Interventions: Device: somofilcon A multifocal lens

Registration Number: NCT03519919

Lead Sponsor: Coopervision, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Somofilcon A multifocal lens	somofilcon A multifocal lens	Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.

Primary Outcome Measures

Name	Time	Method
Vision Clarity During the Day - Distance Vision	3 weeks	Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	3 weeks	Distance visual acuity (logMAR)
Ease of Insertion	3 weeks	Subjective rating how easy lens was inserted on eye for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Ease of Removal	3 weeks	Subjective rating for somofilcon A multifocal lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Overall Satisfaction Preference Between Study and Habitual Contact Lenses	3 weeks	Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations))
Corneal Staining	3 weeks	Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.
Conjunctival Staining	3 weeks	Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentationfor following regions: Temporal, Superior, Nasal, Inferior.
Subjective Vision Satisfaction - Near Vision	3 weeks	Subjective satisfaction of near vision while reading on cell phone and hand-held materials for somofilcon A multifocal lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)
Overall Satisfaction With Speed of Changing Focus	3 weeks	Subjective rating for speed and ability to change focus between distances for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle	3 weeks	Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)
Post-blink Lens Movement	3 weeks	Movement of lens on eye after blink was graded on a 5-point scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable , and 4 - excessive unacceptable.
Bulbar Hyperemia	3 weeks	Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Subjective Vision Satisfaction - Long Intermediate Vision	3 weeks	Subjective satisfaction of long intermediate vision while using desktop computer for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Overall Comfort	3 weeks	Subjective rating of comfort for habitual lens and somofilcon A multifocal lens at 3 weeks (Prefer my own strongly, Prefer my own slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)
Number of Participants With Lens Centration	3 weeks	Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (\>=0.5mm))
Subjective Vision Satisfaction - Driving at Night	3 weeks	Subjective satisfaction of distance vision while driving at night responses for somofilcon A multifocal lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)
Subjective Vision Satisfaction - Short Intermediate Tasks	3 weeks	Subjective satisfaction of short/intermediate vision while using laptop/tablet for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)