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Completed

NCT Number: NCT04105842

Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type

The purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. Ocular signs and symptoms of dry eye will be assessed following the guidelines outlined by the Tear Film and Ocular Surface Society (TFOS) in the Dry Eye Workshop II (DEWS II). The performance of the habitual contact lenses and the study lenses will be determined using different optometric assessments. Study lenses will be worn for one month following a daily disposable wear schedule.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research & Education

Waterloo, Ontario, N2B 3K4, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • As per TFOS DEWS II, have dry eye symptoms (without CL wear) as determined by an OSDI score of ≥13 and at least one of the following:
  • Tear osmolarity ≥ 308mOsm/L or interocular difference >8 mOsm/L
  • Non-invasive tear breakup time of < 10 seconds in at least one eye
  • More than 5 spots of corneal staining OR > 9 conjunctival spots in at least one eye
  • Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203
  • Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D
  • Manifest spectacle cyl ≤1.00DC in either eye
  • BCVA ≤0.20 log MAR each eye with habitual & DT1
  • Acceptable fit with habitual & DT1
  • Willing to wear DT1 CLs at least 3 days per week and 6 hours per day throughout the study

Exclusion criteria

  • Is participating in any concurrent clinical or research study;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
  • Is aphakic;
  • Has undergone refractive error surgery;
  • Has taken part in another clinical research study within the last 14 days;
  • Current habitual wearer of DT1
  • Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.
  • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Treatment and study plan

Delfilcon A

Device

Participants wear delafilcon A contact lenses on a daily disposable basis.

Other names: Dailies Total 1

Primary outcomes

  1. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 1 after screening with habitual lenses

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  2. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 3 after screening with habitual lenses

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  3. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 5 after screening with habitual lenses

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  4. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: 1-week follow up with habitual lens

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  5. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 1 after dispense with delefilcon A

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  6. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 3 after dispense with delefilcon A

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  7. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 5 after dispense with delefilcon A

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  8. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 7 after dispense with delefilcon A

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  9. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 21 after dispense with delefilcon A

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  10. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: Day 28 after dispense with delefilcon A

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  11. Subjective Comfort at End of Day With Contact Lens Wear

    Time frame: 1-month follow up with delefilcon A

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

  12. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 1 after screening with habitual lenses

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  13. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 3 after screening with habitual lenses

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  14. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 5 after screening with habitual lenses

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  15. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: 1-week follow up with habitual lens

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  16. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 1 after dispense with delefilcon A

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  17. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 3 after dispense with delefilcon A

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  18. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 5 after dispense with delefilcon A

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  19. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 7 after dispense with delefilcon A

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  20. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 21 after dispense with delefilcon A

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  21. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: Day 28 after dispense with delefilcon A

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  22. Subjective Rating of End of Day Dryness With Contact Lens Wear

    Time frame: 1-month follow up with delefilcon A

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

  23. Average Lens Wear Time

    Time frame: Day 1 after screening with habitual lenses

    Average lens wear time is recorded

  24. Average Lens Wear Time

    Time frame: Day 3 after screening with habitual lenses

    Average lens wear time is recorded

  25. Average Lens Wear Time

    Time frame: Day 5 after screening with habitual lenses

    Average lens wear time is recorded

  26. Average Lens Wear Time

    Time frame: 1-week follow up with habitual lens

    Average lens wear time is recorded

  27. Average Lens Wear Time

    Time frame: Day 1 after dispense with delefilcon A

    Average lens wear time is recorded

  28. Average Lens Wear Time

    Time frame: Day 3 after dispense with delefilcon A

    Average lens wear time is recorded

  29. Average Lens Wear Time

    Time frame: Day 5 after dispense with delefilcon A

    Average lens wear time is recorded

  30. Average Lens Wear Time

    Time frame: Day 7 after dispense with delefilcon A

    Average lens wear time is recorded

  31. Average Lens Wear Time

    Time frame: Day 21 after dispense with delefilcon A

    Average lens wear time is recorded

  32. Average Lens Wear Time

    Time frame: Day 28 after dispense with delefilcon A

    Average lens wear time is recorded

  33. Average Lens Wear Time

    Time frame: 1-month follow up with delefilcon A

    Average lens wear time is recorded

  34. Comfortable Lens Wear Time

    Time frame: Day 1 after screening with habitual lenses

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  35. Comfortable Lens Wear Time

    Time frame: Day 3 after screening with habitual lenses

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  36. Comfortable Lens Wear Time

    Time frame: Day 5 after screening with habitual lenses

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  37. Comfortable Lens Wear Time

    Time frame: 1-week follow up with habitual lens

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  38. Comfortable Lens Wear Time

    Time frame: Day 1 after dispense with delefilcon A

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  39. Comfortable Lens Wear Time

    Time frame: Day 3 after dispense with delefilcon A

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  40. Comfortable Lens Wear Time

    Time frame: Day 5 after dispense with delefilcon A

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  41. Comfortable Lens Wear Time

    Time frame: Day 7 after dispense with delefilcon A

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  42. Comfortable Lens Wear Time

    Time frame: Day 21 after dispense with delefilcon A

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  43. Comfortable Lens Wear Time

    Time frame: Day 28 after dispense with delefilcon A

    Comfortable lens wear time (Time of discomfort - Time of insertion)

  44. Comfortable Lens Wear Time

    Time frame: 1-month follow up with delefilcon A

    Comfortable lens wear time (Time of discomfort - Time of insertion)

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Acronym: CORGI

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2019
Registry last updated
Jul 25, 2023

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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