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

Study Overview
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Brief Summary
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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.

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

Conditions
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Presbyopia

Intervention / Treatment
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* Device: somofilcon A multifocal lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |