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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Delfilcon A

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2B 3K4
      • Centre for Ocular Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Dailies Total 1

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 41251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes