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

Dry Eye Clinical Trial

— CORGI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105842
• Other study ID #: 41251
• Status: Completed
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: July 28, 2022

Study information

• Verified date: June 2023
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Delfilcon A
Participants wear delafilcon A contact lenses on a daily disposable basis.

Locations

Country	Name	City	State
Canada	Centre for Ocular Research & Education	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 1 after screening with habitual lenses
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 3 after screening with habitual lenses
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 5 after screening with habitual lenses
Primary	Average Lens Wear Time	Average lens wear time is recorded	1-week follow up with habitual lens
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 1 after dispense with delefilcon A
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 3 after dispense with delefilcon A
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 5 after dispense with delefilcon A
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 7 after dispense with delefilcon A
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 21 after dispense with delefilcon A
Primary	Average Lens Wear Time	Average lens wear time is recorded	Day 28 after dispense with delefilcon A
Primary	Average Lens Wear Time	Average lens wear time is recorded	1-month follow up with delefilcon A
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 1 after screening with habitual lenses
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 3 after screening with habitual lenses
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 5 after screening with habitual lenses
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	1-week follow up with habitual lens
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 1 after dispense with delefilcon A
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 3 after dispense with delefilcon A
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 5 after dispense with delefilcon A
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 7 after dispense with delefilcon A
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 21 after dispense with delefilcon A
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	Day 28 after dispense with delefilcon A
Primary	Comfortable Lens Wear Time	Comfortable lens wear time (Time of discomfort - Time of insertion)	1-month follow up with delefilcon A