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OpenTrials
Completed

NCT Number: NCT04067050

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

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.

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Key information

Conditions

Ametropia Eye Diseases Refractive Errors

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research - The University of Manchester

Manchester, M13 9PL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

comfilcon A asphere

Device

Contact Lens

Other names: test

Spectacles

Device

Habitual spectacles

Other names: Control, Single Vision Spectacles

Primary outcomes

  1. Symptom of Burning

    Time frame: Baseline

    Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  2. Symptom of Burning

    Time frame: 1 month

    Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  3. Symptom of Burning

    Time frame: 2 months

    Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  4. Symptom of Itching

    Time frame: Baseline

    Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  5. Symptom of Itching

    Time frame: One Month

    Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  6. Symptom of Itching

    Time frame: Two Months

    Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  7. Symptom of Feeling of Foreign Body

    Time frame: Baseline

    Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  8. Symptom of Feeling of Foreign Body

    Time frame: One Month

    Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  9. Symptom of Feeling of Foreign Body

    Time frame: Two Months

    Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  10. Symptom of Tearing

    Time frame: Baseline

    Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  11. Symptom of Tearing

    Time frame: One Month

    Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  12. Symptom of Tearing

    Time frame: Two Months

    Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  13. Symptom of Excessive Blinking

    Time frame: Baseline

    Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  14. Symptom of Excessive Blinking

    Time frame: One Month

    Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  15. Symptom of Excessive Blinking

    Time frame: Two Months

    Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  16. Symptom of Eye Redness

    Time frame: Baseline

    Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  17. Symptom of Eye Redness

    Time frame: One Month

    Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  18. Symptom of Eye Redness

    Time frame: Two Months

    Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  19. Symptom of Eye Pain

    Time frame: Baseline

    Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  20. Symptom of Eye Pain

    Time frame: One Month

    Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  21. Symptom of Eye Pain

    Time frame: Two Months

    Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  22. Symptom of Heavy Eyelids

    Time frame: Baseline

    Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  23. Symptom of Heavy Eyelids

    Time frame: One Month

    Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  24. Symptom of Heavy Eyelids

    Time frame: Two Months

    Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  25. Symptom of Dryness

    Time frame: Baseline

    Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  26. Symptom of Dryness

    Time frame: One Month

    Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  27. Symptom of Dryness

    Time frame: Two Months

    Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  28. Symptom of Blurred Vision

    Time frame: Baseline

    Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  29. Symptom of Blurred Vision

    Time frame: One Month

    Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  30. Symptom of Blurred Vision

    Time frame: Two Months

    Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  31. Symptom of Double Vision

    Time frame: Baseline

    Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  32. Symptom of Double Vision

    Time frame: One Month

    Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  33. Symptom of Double Vision

    Time frame: Two Months

    Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  34. Symptom of Difficulty Focusing For Near Vision

    Time frame: Baseline

    Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  35. Symptom of Difficulty Focusing For Near Vision

    Time frame: One Month

    Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  36. Symptom of Difficulty Focusing For Near Vision

    Time frame: Two Months

    Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  37. Symptom of Increased Sensitivity to Light

    Time frame: Baseline

    Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  38. Symptom of Increased Sensitivity to Light

    Time frame: One Month

    Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  39. Symptom of Increased Sensitivity to Light

    Time frame: Two Months

    Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  40. Symptom of Colored Haloes Around Objects

    Time frame: Baseline

    Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  41. Symptom of Colored Haloes Around Objects

    Time frame: One Month

    Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  42. Symptom of Colored Halos Around Objects

    Time frame: Two Months

    Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  43. Symptom of Feeling That Sight is Worsening

    Time frame: Baseline

    Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  44. Symptom of Feeling That Sight is Worsening

    Time frame: One Month

    Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  45. Symptom of Feeling That Sight is Worsening

    Time frame: Two Months

    Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  46. Symptom of Headache

    Time frame: Baseline

    Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  47. Symptom of Headache

    Time frame: One Month

    Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

  48. Symptom of Headache

    Time frame: Two Months

    Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 26, 2019
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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