Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type (CORGI)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Waterloo, Ontario, Canada, N2B 3K4
- Centre for Ocular Research & Education
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Delfilcon A
All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month.
|
Participants wear delafilcon A contact lenses on a daily disposable basis.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Day 1 after screening with habitual lenses
|
|
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).
|
Day 3 after screening with habitual lenses
|
|
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).
|
Day 5 after screening with habitual lenses
|
|
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).
|
1-week follow up with habitual lens
|
|
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).
|
Day 1 after dispense with delefilcon A
|
|
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).
|
Day 3 after dispense with delefilcon A
|
|
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).
|
Day 5 after dispense with delefilcon A
|
|
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).
|
Day 7 after dispense with delefilcon A
|
|
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).
|
Day 21 after dispense with delefilcon A
|
|
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).
|
Day 28 after dispense with delefilcon A
|
|
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).
|
1-month follow up with delefilcon A
|
|
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).
|
Day 1 after screening with habitual lenses
|
|
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).
|
Day 3 after screening with habitual lenses
|
|
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).
|
Day 5 after screening with habitual lenses
|
|
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).
|
1-week follow up with habitual lens
|
|
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).
|
Day 1 after dispense with delefilcon A
|
|
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).
|
Day 3 after dispense with delefilcon A
|
|
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).
|
Day 5 after dispense with delefilcon A
|
|
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).
|
Day 7 after dispense with delefilcon A
|
|
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).
|
Day 21 after dispense with delefilcon A
|
|
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).
|
Day 28 after dispense with delefilcon A
|
|
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).
|
1-month follow up with delefilcon A
|
|
Average Lens Wear Time
Time Frame: Day 1 after screening with habitual lenses
|
Average lens wear time is recorded
|
Day 1 after screening with habitual lenses
|
|
Average Lens Wear Time
Time Frame: Day 3 after screening with habitual lenses
|
Average lens wear time is recorded
|
Day 3 after screening with habitual lenses
|
|
Average Lens Wear Time
Time Frame: Day 5 after screening with habitual lenses
|
Average lens wear time is recorded
|
Day 5 after screening with habitual lenses
|
|
Average Lens Wear Time
Time Frame: 1-week follow up with habitual lens
|
Average lens wear time is recorded
|
1-week follow up with habitual lens
|
|
Average Lens Wear Time
Time Frame: Day 1 after dispense with delefilcon A
|
Average lens wear time is recorded
|
Day 1 after dispense with delefilcon A
|
|
Average Lens Wear Time
Time Frame: Day 3 after dispense with delefilcon A
|
Average lens wear time is recorded
|
Day 3 after dispense with delefilcon A
|
|
Average Lens Wear Time
Time Frame: Day 5 after dispense with delefilcon A
|
Average lens wear time is recorded
|
Day 5 after dispense with delefilcon A
|
|
Average Lens Wear Time
Time Frame: Day 7 after dispense with delefilcon A
|
Average lens wear time is recorded
|
Day 7 after dispense with delefilcon A
|
|
Average Lens Wear Time
Time Frame: Day 21 after dispense with delefilcon A
|
Average lens wear time is recorded
|
Day 21 after dispense with delefilcon A
|
|
Average Lens Wear Time
Time Frame: Day 28 after dispense with delefilcon A
|
Average lens wear time is recorded
|
Day 28 after dispense with delefilcon A
|
|
Average Lens Wear Time
Time Frame: 1-month follow up with delefilcon A
|
Average lens wear time is recorded
|
1-month follow up with delefilcon A
|
|
Comfortable Lens Wear Time
Time Frame: Day 1 after screening with habitual lenses
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 1 after screening with habitual lenses
|
|
Comfortable Lens Wear Time
Time Frame: Day 3 after screening with habitual lenses
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 3 after screening with habitual lenses
|
|
Comfortable Lens Wear Time
Time Frame: Day 5 after screening with habitual lenses
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 5 after screening with habitual lenses
|
|
Comfortable Lens Wear Time
Time Frame: 1-week follow up with habitual lens
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
1-week follow up with habitual lens
|
|
Comfortable Lens Wear Time
Time Frame: Day 1 after dispense with delefilcon A
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 1 after dispense with delefilcon A
|
|
Comfortable Lens Wear Time
Time Frame: Day 3 after dispense with delefilcon A
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 3 after dispense with delefilcon A
|
|
Comfortable Lens Wear Time
Time Frame: Day 5 after dispense with delefilcon A
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 5 after dispense with delefilcon A
|
|
Comfortable Lens Wear Time
Time Frame: Day 7 after dispense with delefilcon A
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 7 after dispense with delefilcon A
|
|
Comfortable Lens Wear Time
Time Frame: Day 21 after dispense with delefilcon A
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 21 after dispense with delefilcon A
|
|
Comfortable Lens Wear Time
Time Frame: Day 28 after dispense with delefilcon A
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
Day 28 after dispense with delefilcon A
|
|
Comfortable Lens Wear Time
Time Frame: 1-month follow up with delefilcon A
|
Comfortable lens wear time (Time of discomfort - Time of insertion)
|
1-month follow up with delefilcon A
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 41251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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