A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

CooperVision, Inc.55 enrolled

Overview

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

comfilcon ADEVICE

Contact Lens

somofilcon ADEVICE

daily disposable contact lens

stenfilcon ADEVICE

daily disposable contact lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects will only be eligible for the study if: * They are between 18 and 40 years of age (inclusive). * They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. * They are willing and able to follow the protocol. * They are an existing soft reusable spherical contact lens wearer in both eyes. * They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction. * They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction * They own a wearable pair of spectacles and wear them on the day of the initial visit. * They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles. * They agree not to participate in other clinical research for the duration of the study. Exclusion Criteria: * They have an ocular disorder which would normally contra-indicate contact lens wear. * They have a systemic disorder which would normally contra-indicate contact lens wear. * They are using any topical medication such as eye drops or ointment. * They are aphakic. * They have had corneal refractive surgery. * They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * They are pregnant or breastfeeding. * They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. * They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Locations (1)

Eurolens Research - The University of Manchester

Manchester, United Kingdom

Outcomes

Primary Outcomes

Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use

Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Time frame: 4 weeks

Subjective Scores of Comfort on Insertion

Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Time frame: 1 week

Secondary Outcomes

Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use

Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Time frame: 4 weeks

Subjective Scores on Overall Comfort

Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Time frame: 1 week

Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use

Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Time frame: 4 weeks

Subjective Scores on Comfort Before Removal

Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Time frame: 1 week

Number of Participants With Horizontal Lens Centration Grade

Data from ClinicalTrials.gov

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Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

Time frame: Baseline (after 5 minutes of lens dispense)

Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear

Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

Time frame: 4 weeks

Number of Participants With Horizontal Lens Centration Grade

Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

Time frame: 1 week

Number of Participants With Vertical Lens Centration Grade

Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

Time frame: Baseline (After 5 minutes of lens dispense)

Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear

Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

Time frame: 4 weeks

Number of Participants With Vertical Lens Centration Grade

Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

Time frame: 1 week

Number of Participants With Lens Corneal Coverage Grade

Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

Time frame: Baseline (after 5 minutes of lens dispense)

Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear

Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

Time frame: 4 weeks

Number of Participants With Lens Corneal Coverage Grade

Time frame: 1 week

Number of Participants With Post-Blink Movement Grade

Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

Time frame: Baseline (after 5 minutes of lens dispense)

Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear

Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

Time frame: 4 weeks

Number of Participants With Post-Blink Movement Grade

Time frame: 1 week

Investigator Lens Fit Acceptance

Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

Time frame: Baseline (after 5 minutes of lens dispense)

Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use

Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

Time frame: 4 weeks

Investigator Lens Fit Acceptance

Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

Time frame: 1 week