Status:
COMPLETED
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
17+ years
Phase:
NA
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 di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04105842
Start Date
September 23 2019
End Date
July 28 2022
Last Update
July 25 2023
Active Locations (1)
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1
Centre for Ocular Research & Education
Waterloo, Ontario, Canada, N2B 3K4