Clinical trial NCT04105842: Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
Official title: Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2019-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. 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:

   1. Tear osmolarity ≥ 308mOsm/L or interocular difference \>8 mOsm/L
   2. Non-invasive tear breakup time of \< 10 seconds in at least one eye
   3. More than 5 spots of corneal staining OR \> 9 conjunctival spots in at least one eye
5. Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203
6. Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D
7. Manifest spectacle cyl ≤1.00DC in either eye
8. BCVA ≤0.20 log MAR each eye with habitual \& DT1
9. Acceptable fit with habitual \& DT1
10. Willing to wear DT1 CLs at least 3 days per week and 6 hours per day throughout the study

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has taken part in another clinical research study within the last 14 days;
10. Current habitual wearer of DT1
11. 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.

Primary outcomes:
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 1 after screening with habitual lenses
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 3 after screening with habitual lenses
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 5 after screening with habitual lenses
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: 1-week follow up with habitual lens
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 1 after dispense with delefilcon A
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 3 after dispense with delefilcon A
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 5 after dispense with delefilcon A
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 7 after dispense with delefilcon A
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 21 after dispense with delefilcon A
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: Day 28 after dispense with delefilcon A
measure: Subjective Comfort at End of Day With Contact Lens Wear
timeFrame: 1-month follow up with delefilcon A
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 1 after screening with habitual lenses
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 3 after screening with habitual lenses
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 5 after screening with habitual lenses
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: 1-week follow up with habitual lens
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 1 after dispense with delefilcon A
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 3 after dispense with delefilcon A
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 5 after dispense with delefilcon A
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 7 after dispense with delefilcon A
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 21 after dispense with delefilcon A
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: Day 28 after dispense with delefilcon A
measure: Subjective Rating of End of Day Dryness With Contact Lens Wear
timeFrame: 1-month follow up with delefilcon A
measure: Average Lens Wear Time
timeFrame: Day 1 after screening with habitual lenses
measure: Average Lens Wear Time
timeFrame: Day 3 after screening with habitual lenses
measure: Average Lens Wear Time
timeFrame: Day 5 after screening with habitual lenses
measure: Average Lens Wear Time
timeFrame: 1-week follow up with habitual lens
measure: Average Lens Wear Time
timeFrame: Day 1 after dispense with delefilcon A
measure: Average Lens Wear Time
timeFrame: Day 3 after dispense with delefilcon A
measure: Average Lens Wear Time
timeFrame: Day 5 after dispense with delefilcon A
measure: Average Lens Wear Time
timeFrame: Day 7 after dispense with delefilcon A
measure: Average Lens Wear Time
timeFrame: Day 21 after dispense with delefilcon A
measure: Average Lens Wear Time
timeFrame: Day 28 after dispense with delefilcon A
measure: Average Lens Wear Time
timeFrame: 1-month follow up with delefilcon A
measure: Comfortable Lens Wear Time
timeFrame: Day 1 after screening with habitual lenses
measure: Comfortable Lens Wear Time
timeFrame: Day 3 after screening with habitual lenses
measure: Comfortable Lens Wear Time
timeFrame: Day 5 after screening with habitual lenses
measure: Comfortable Lens Wear Time
timeFrame: 1-week follow up with habitual lens
measure: Comfortable Lens Wear Time
timeFrame: Day 1 after dispense with delefilcon A
measure: Comfortable Lens Wear Time
timeFrame: Day 3 after dispense with delefilcon A
measure: Comfortable Lens Wear Time
timeFrame: Day 5 after dispense with delefilcon A
measure: Comfortable Lens Wear Time
timeFrame: Day 7 after dispense with delefilcon A
measure: Comfortable Lens Wear Time
timeFrame: Day 21 after dispense with delefilcon A
measure: Comfortable Lens Wear Time
timeFrame: Day 28 after dispense with delefilcon A
measure: Comfortable Lens Wear Time
timeFrame: 1-month follow up with delefilcon A
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education
state: Ontario
Study officials:
affiliation: Centre for Ocular Research & Education
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References: