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

N/ACompletedNCT03519919

CooperVision, Inc.51 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Presbyopia

Interventions

somofilcon A multifocal lensDEVICE

contact lens

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 3 weeks

Secondary Outcomes

Number of Participants With Lens Centration

Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (\>=0.5mm))

Time frame: Baseline

Number of Participants With Lens Centration

Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (\>=0.5mm))

Time frame: 3 weeks

Visual Acuity

Distance visual acuity (logMAR)

Time frame: Baseline

Visual Acuity

Distance visual acuity (logMAR)

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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.

Time frame: Baseline

Corneal Staining

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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))

Time frame: 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)

Time frame: 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)

Time frame: 3 weeks