CORGI: Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Delfilcon A All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. |
Device: Delfilcon A
Participants wear delafilcon A contact lenses on a daily disposable basis.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Subjective Comfort at End of Day with contact lens wear [Day 1 after screening with habitual lenses]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 3 after screening with habitual lenses]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 5 after screening with habitual lenses]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [1-week follow up with habitual lens]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 1 after dispense with delefilcon A]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 3 after dispense with delefilcon A]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 5 after dispense with delefilcon A]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 7 after dispense with delefilcon A]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 21 after dispense with delefilcon A]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [Day 28 after dispense with delefilcon A]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Comfort at End of Day with contact lens wear [1-month follow up with delefilcon A]
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 1 after screening with habitual lenses]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 3 after screening with habitual lenses]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 5 after screening with habitual lenses]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [1-week follow up with habitual lens]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 1 after dispense with delefilcon A]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 3 after dispense with delefilcon A]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 5 after dispense with delefilcon A]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 7 after dispense with delefilcon A]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 21 after dispense with delefilcon A]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [Day 28 after dispense with delefilcon A]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Subjective Rating of End of Day Dryness with contact lens wear [1-month follow up with delefilcon A]
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
- Average lens wear time [Day 1 after screening with habitual lenses]
Average lens wear time is recorded
- Average lens wear time [Day 3 after screening with habitual lenses]
Average lens wear time is recorded
- Average lens wear time [Day 5 after screening with habitual lenses]
Average lens wear time is recorded
- Average lens wear time [1-week follow up with habitual lens]
Average lens wear time is recorded
- Average lens wear time [Day 1 after dispense with delefilcon A]
Average lens wear time is recorded
- Average lens wear time [Day 3 after dispense with delefilcon A]
Average lens wear time is recorded
- Average lens wear time [Day 5 after dispense with delefilcon A]
Average lens wear time is recorded
- Average lens wear time [Day 7 after dispense with delefilcon A]
Average lens wear time is recorded
- Average lens wear time [Day 21 after dispense with delefilcon A]
Average lens wear time is recorded
- Average lens wear time [Day 28 after dispense with delefilcon A]
Average lens wear time is recorded
- Average lens wear time [1-month follow up with delefilcon A]
Average lens wear time is recorded
- Comfortable lens wear time [Day 1 after screening with habitual lenses]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 3 after screening with habitual lenses]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 5 after screening with habitual lenses]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [1-week follow up with habitual lens]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 1 after dispense with delefilcon A]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 3 after dispense with delefilcon A]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 5 after dispense with delefilcon A]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 7 after dispense with delefilcon A]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 21 after dispense with delefilcon A]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [Day 28 after dispense with delefilcon A]
Comfortable lens wear time (Time of discomfort - Time of insertion)
- Comfortable lens wear time [1-month follow up with delefilcon A]
Comfortable lens wear time (Time of discomfort - Time of insertion)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Is at least 17 years of age and has full legal capacity to volunteer;
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Has read and signed an information consent letter;
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Is willing and able to follow instructions and maintain the appointment schedule;
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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:
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Tear osmolarity ≥ 308mOsm/L or interocular difference >8 mOsm/L
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Non-invasive tear breakup time of < 10 seconds in at least one eye
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More than 5 spots of corneal staining OR > 9 conjunctival spots in at least one eye
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Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203
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Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D
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Manifest spectacle cyl ≤1.00DC in either eye
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BCVA ≤0.20 log MAR each eye with habitual & DT1
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Acceptable fit with habitual & DT1
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Willing to wear DT1 CLs at least 3 days per week and 6 hours per day throughout the study
Exclusion Criteria:
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Is participating in any concurrent clinical or research study;
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Has any known active* ocular disease and/or infection;
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Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
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Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
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Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
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Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
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Is aphakic;
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Has undergone refractive error surgery;
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Has taken part in another clinical research study within the last 14 days;
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Current habitual wearer of DT1
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Centre for Ocular Research & Education | Waterloo | Ontario | Canada | N2B 3K4 |
Sponsors and Collaborators
- University of Waterloo
- Alcon Research
Investigators
- Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 41251