A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: comfilcon A; Device: somofilcon A; Device: stenfilcon A

Detailed Description

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
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • Eurolens Research - The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: somofilcon A then stenfilcon A contact lens; Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.	Device: comfilcon A; Contact Lens; Other Names: Control Lens; Device: somofilcon A; daily disposable contact lens; Other Names: somofilcon A daily disposable test lens; Test lens 1; Device: stenfilcon A; daily disposable contact lens; Other Names: stenfilcon A daily disposable test lens; Test lens 2
Experimental: stenfilcon A then somofilcon A contact lens; Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.	Device: comfilcon A; Contact Lens; Other Names: Control Lens; Device: somofilcon A; daily disposable contact lens; Other Names: somofilcon A daily disposable test lens; Test lens 1; Device: stenfilcon A; daily disposable contact lens; Other Names: stenfilcon A daily disposable test lens; Test lens 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	1 week
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)	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)	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)	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)	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)	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)	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)	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)	4 weeks
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)	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)	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)	4 weeks
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)	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)	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)	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)	1 week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-100

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