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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye

Intervention / Treatment
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* Device: Delfilcon A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delfilcon A<br>All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. | Device: Delfilcon A<br>* Participants wear delafilcon A contact lenses on a daily disposable basis.<br>* Other names: Dailies Total 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort at End of Day With Contact Lens Wear | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Average lens wear time is recorded | Day 1 after screening with habitual lenses | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 3 after screening with habitual lenses | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 5 after screening with habitual lenses | 
| Average Lens Wear Time | Average lens wear time is recorded | 1-week follow up with habitual lens | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 1 after dispense with delefilcon A | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 3 after dispense with delefilcon A | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 5 after dispense with delefilcon A | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 7 after dispense with delefilcon A | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 21 after dispense with delefilcon A | 
| Average Lens Wear Time | Average lens wear time is recorded | Day 28 after dispense with delefilcon A | 
| Average Lens Wear Time | Average lens wear time is recorded | 1-month follow up with delefilcon A | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 1 after screening with habitual lenses | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 3 after screening with habitual lenses | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 5 after screening with habitual lenses | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | 1-week follow up with habitual lens | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 1 after dispense with delefilcon A | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 3 after dispense with delefilcon A | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 5 after dispense with delefilcon A | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 7 after dispense with delefilcon A | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 21 after dispense with delefilcon A | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Day 28 after dispense with delefilcon A | 
| Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | 1-month follow up with delefilcon A |