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A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices

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: NCT04067050
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
The aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.

Condition or disease Intervention/treatment Phase
Ametropia Device: comfilcon A asphere Device: Spectacles Not Applicable

Detailed Description:
The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. Subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: comfilcon A asphere
Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week.
Device: comfilcon A asphere
Contact Lens
Other Names:
  • test
  • Biofinity Energys

Active Comparator: Habitual Spectacles
Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week.
Device: Spectacles
Habitual spectacles
Other Names:
  • Control
  • Single Vision Spectacles




Primary Outcome Measures :
  1. Symptom of Burning [ Time Frame: Up to 2 months ]
    Symptom of burning measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  2. Symptom of Itching [ Time Frame: Up to 2 months ]
    Symptom of itching measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  3. Symptom of Feeling of Foreign Body [ Time Frame: Up to 2 months ]
    Symptom of feeling of foreign body measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  4. Symptom of Tearing [ Time Frame: Up to 2 months ]
    Symptom of tearing measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  5. Symptom of Excessive Blinking [ Time Frame: Up to 2 months ]
    Symptom of excessive blinking measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  6. Symptom of Eye Redness [ Time Frame: Up to 2 months ]
    Symptom of eye redness measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  7. Symptom of Eye Pain [ Time Frame: Up to 2 months ]
    Symptom of eye pain measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  8. Symptom of Heavy Eyelids [ Time Frame: Up to 2 months ]
    Symptom of heavy eyelids measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  9. Symptom of Dryness [ Time Frame: Up to 2 months ]
    Symptom of dryness measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  10. Symptom of Blurred Vision [ Time Frame: Up to 2 months ]
    Symptom of blurred vision measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  11. Symptom of Double Vision [ Time Frame: Up to 2 months ]
    Symptom of double vision measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  12. Symptom of Difficulty Focusing For Near Vision [ Time Frame: Up to 2 months ]
    Symptom of difficulty focusing for near vision measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  13. Symptom of Increased Sensitivity to Light [ Time Frame: Up to 2 months ]
    Symptom of increased sensitivity to light measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  14. Symptom of Colored Halos Around Objects [ Time Frame: Up to 2 months ]
    Symptom of colored halos around objects measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  15. Symptom of Feeling That Sight is Worsening [ Time Frame: Up to 2 months ]
    Symptom of feeling that sight is worsening measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).

  16. Symptom of headache [ Time Frame: Up to 2 months ]
    Symptom of headache measured by frequency (never=does not occur at all, occasionally=sporadic episodes/once a week, or often/always=2 or 3 times a week/almost every day) and intensity (measured by: moderate or intense when symptom is experienced).



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 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • They are between 18 and 35 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 a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting, lasting up to one week).
  • They have a contact lens spherical prescription between -1.00 to -6.25D (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 and habitually wear single vision spectacles used for both distance and near vision, including computer and digital device use.
  • Their single vision spectacles have a mean sphere equivalent within ±0.50D of that of the refraction found in the study for each eye (after having taken lens effectivity into account).
  • They are willing to be fitted with contact lenses and understand they may be randomized to either group.
  • They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
  • They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
  • They agree not to change the spectacles they will wear for digital device use for the duration of the study.
  • 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 (including comfort drops) or ointment on a regular basis.
  • The spectacles they use for digital device viewing on the study have been made with specialist features for computer use, digital eye fatigue or are multifocal/bifocal.
  • 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 evidence of a heterotropia or decompensating heterotropia on cover test.
  • They have a history of having been prescribed prism in their spectacles (by self report).
  • 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): NCT04067050


Locations
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United Kingdom
Eurolens Research - The University of Manchester
Manchester, United Kingdom, M13 9PL
Sponsors and Collaborators
Coopervision, Inc.
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT04067050    
Other Study ID Numbers: EX-MKTG-105
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: May 5, 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