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

Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: somofilcon A multifocal lens

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somofilcon A multifocal lens; Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.	Device: somofilcon A multifocal lens; contact lens; Other Names: clarifi multifocal lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vision Clarity During the Day - Distance Vision	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	Baseline
Vision Clarity During the Day - Distance Vision	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	3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): September 22, 2018
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EX-MKTG-81

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes