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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04105842

Acronym

CORGI

Enrollment

Registered

2019-09-26

Start date

2019-09-23

Completion date

2022-07-28

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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.

Interventions

DEVICEDelfilcon A

Participants wear delafilcon A contact lenses on a daily disposable basis.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Masking description

Participants will be masked to the lens type (brand) they will be wearing during the study in order to reduce bias towards or against this product

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Subjective Comfort at End of Day With Contact Lens Wear	Day 1 after screening with habitual lenses	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Subjective Rating of End of Day Dryness With Contact Lens Wear	Day 1 after screening with habitual lenses	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Average Lens Wear Time	Day 1 after screening with habitual lenses	Average lens wear time is recorded
Comfortable Lens Wear Time	Day 1 after screening with habitual lenses	Comfortable lens wear time (Time of discomfort - Time of insertion)

Countries

Canada

Participant flow

Recruitment details

Participants were recruited at a single site between September 2019 and June 2022. The first participant was enrolled on September 23, 2019 and the last participant was enrolled on June 23, 2022.

Pre-assignment details

Out of 40 participants enrolled, 37 met the inclusion criteria.

Participants by arm

Arm	Count
Delfilcon A All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.	37
Total	37

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Delfilcon A
Age, Categorical <=18 years	1 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	36 Participants
Age, Continuous	26.1 years STANDARD_DEVIATION 8.2
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Region of Enrollment Canada	37 participants
Sex: Female, Male Female	29 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 37	0 / 35	0 / 37	0 / 35
other Total, other adverse events	1 / 37	1 / 35	0 / 37	0 / 35
serious Total, serious adverse events	0 / 37	0 / 35	0 / 37	0 / 35

Outcome results

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: 1-month follow up with delefilcon A

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	12.5 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 28 after dispense with delefilcon A

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	12.0 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 21 after dispense with delefilcon A

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	12.1 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 1 after screening with habitual lenses

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	10.9 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 3 after screening with habitual lenses

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	11.4 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 5 after screening with habitual lenses

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	11.4 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: 1-week follow up with habitual lens

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	12 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 1 after dispense with delefilcon A

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	11.0 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 3 after dispense with delefilcon A

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	10.4 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 5 after dispense with delefilcon A

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	12.0 hours per day

Primary

Average Lens Wear Time

Average lens wear time is recorded

Time frame: Day 7 after dispense with delefilcon A

Arm	Measure	Value (MEDIAN)
Delfilcon A	Average Lens Wear Time	11.7 hours per day

Primary