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The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable 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: NCT04067141
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Condition or disease Intervention/treatment Phase
Ametropia Device: somofilcon A Device: nelfilcon A Not Applicable

Detailed Description:

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a bilateral crossover study
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: somofilcon A, then nelfilcon A
Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.
Device: somofilcon A
Contact Lens
Other Names:
  • somofilcon A 1 day
  • test lens
  • clariti 1 day

Device: nelfilcon A
Contact Lens
Other Names:
  • nelfilcon A Daily Disposable Contact Lens
  • control lens
  • DAILIES AquaComfort PLUS daily disposable

Experimental: nelfilcon A, then somofilcon A
Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.
Device: somofilcon A
Contact Lens
Other Names:
  • somofilcon A 1 day
  • test lens
  • clariti 1 day

Device: nelfilcon A
Contact Lens
Other Names:
  • nelfilcon A Daily Disposable Contact Lens
  • control lens
  • DAILIES AquaComfort PLUS daily disposable




Primary Outcome Measures :
  1. Biomicroscopy - Conjunctival Redness Score [ Time Frame: Up to 1 week ]
    Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  2. Biomicroscopy - Limbal Redness Score [ Time Frame: Up to 1 week ]
    Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  3. Biomicroscopy - Corneal Staining Score [ Time Frame: Up to 1 week ]
    Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  4. Biomicroscopy - Conjunctival Staining Score [ Time Frame: Up to 1 week ]
    Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  5. Biomicroscopy - Papillary Conjunctivitis Score [ Time Frame: Up to 1 week ]
    Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).

  6. Horizontal centration - lens fit [ Time Frame: Up to 1 week ]
    Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).

  7. Vertical Centration Grade - lens fit [ Time Frame: Up to 1 week ]
    Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).

  8. Corneal Coverage Grade [ Time Frame: Up to 1 week ]
    Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).

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

  10. Subjective Comfort at Lens Dispensing [ Time Frame: Up to 1 week ]
    Subjective comfort at lens dispensing on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).

  11. Subjective Comfort at Start of Day [ Time Frame: Up to 1 week ]
    Subjective comfort at start of day on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).

  12. Subjective Comfort at End of Day [ Time Frame: Up to 1 week ]
    Subjective comfort at end of day on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).

  13. Overall Subjective Comfort [ Time Frame: Up to 1 week ]
    Overall subjective comfort on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).

  14. Subjective Vision [ Time Frame: Up to 1 week ]
    Subjective Vision rated on scale 1-10 (0=unacceptable, lens cannot be worn to 10=excellent, unaware of an visual loss.)

  15. Ocular Redness Rating [ Time Frame: Up to 1 week ]
    Ocular redness rating rated on a scale 1-10 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • They are of legal age (18) and capacity to volunteer.
  • 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 agree not to participate in other clinical research for the duration of this study.
  • They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
  • They have a maximum of -1.00DC ocular astigmatism in each eye.
  • They can be satisfactorily fitted with the study lens types.
  • At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  • They currently use soft contact lenses or have done so in the previous six months.
  • They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
  • They own a wearable pair of spectacles.

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 have had cataract surgery.
  • 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 breast-feeding.
  • They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  • 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.
  • They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.

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): NCT04067141


Locations
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United Kingdom
Eurolens Research
Manchester, United Kingdom, M13 9PL
Sponsors and Collaborators
Coopervision, Inc.
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT04067141    
Other Study ID Numbers: EX-MKTG-75
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Refractive Errors
Eye Diseases