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A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005885
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

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

Condition or disease Intervention/treatment Phase
Myopia Device: comfilcon A Device: somofilcon A Device: stenfilcon A Not Applicable

Detailed Description:
This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study will compare 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 will wear each daily disposable lens type for one week, in random order.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Subjects and investigators will be masked to the study lenses - lenses will be overlabelled.
Primary Purpose: Other
Official Title: A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : November 8, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: comfilcon A, then somofilcon A, then stenfilcon A contact lens
Participants will be fitted and wear the comfilcon A lens on a daily wear, reusable basis for 1 month, then fitted and wear the somofilcon A daily disposable test lens for 1 week of daily wear, then fitted and wear the stenfilcon A daily disposable test lens for 1 week of daily wear.
Device: comfilcon A
Contact Lens
Other Names:
  • Biofinity Sphere
  • Control Lens

Device: somofilcon A
daily disposable contact lens
Other Names:
  • clariti 1 day
  • somofilcon A daily disposable test lens
  • somofilcon A 1 day test lens
  • Test lens 1

Device: stenfilcon A
daily disposable contact lens
Other Names:
  • MyDay
  • stenfilcon A daily disposable test lens
  • stenfilcon A 1 day test lens
  • Test lens 2

Experimental: comfilcon A, then stenfilcon A, then somofilcon A contact lens
Participants will be fitted and wear the comfilcon A lens on a daily wear, reusable basis for 1 month, then fitted and wear the stenfilcon A daily disposable test lens for 1 week of daily wear, then fitted and wear the somofilcon A daily disposable test lens for 1 week of daily wear.
Device: comfilcon A
Contact Lens
Other Names:
  • Biofinity Sphere
  • Control Lens

Device: somofilcon A
daily disposable contact lens
Other Names:
  • clariti 1 day
  • somofilcon A daily disposable test lens
  • somofilcon A 1 day test lens
  • Test lens 1

Device: stenfilcon A
daily disposable contact lens
Other Names:
  • MyDay
  • stenfilcon A daily disposable test lens
  • stenfilcon A 1 day test lens
  • Test lens 2




Primary Outcome Measures :
  1. Rating of comfort at Insertion Description: Comfort at insertion rated on a scale 0-100 (0 =causes pain, cannot be tolerated, 100 =excellent, cannot be felt). [ Time Frame: Up to 4 weeks ]
    Comfort at insertion rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).


Secondary Outcome Measures :
  1. Overall comfort rating [ Time Frame: Up to 4 weeks ]
    Overall comfort rated on a scale 0100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  2. Comfort before removal rating [ Time Frame: Up to 4 weeks ]
    Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  3. Horizontal Centration Grade [ Time Frame: Up to 4 weeks ]
    Horizontal centration graded by -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal

  4. Vertical Centration Grade [ Time Frame: Up to 4 weeks ]
    Vertical centration graded by -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior

  5. Corneal Coverage Grade [ Time Frame: Up to 4 weeks ]
    Corneal coverage graded by -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive

  6. Post-Blink Movement Grade [ Time Frame: Up to 4 weeks ]
    Post-blink movement graded by -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive

  7. Investigator lens fit acceptance [ Time Frame: Up to 4 weeks ]
    Lens fit acceptance investigator rating on 1-5 Likert Scale (0=strongly agree, 5=strongly disagree)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005885


Locations
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United Kingdom
Eurolens Research - The University of Manchester
Manchester, United Kingdom, M13 9PL
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA Eurolens Research
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT04005885    
Other Study ID Numbers: EX-MKTG-100
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

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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
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases