NCT04105842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 29, 2023

Completed
Last Updated

July 25, 2023

Status Verified

June 1, 2023

Enrollment Period

2.8 years

First QC Date

September 13, 2019

Results QC Date

June 7, 2023

Last Update Submit

July 13, 2023

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (44)

  • 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

Study Arms (1)

Delfilcon A

EXPERIMENTAL

All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month.

Device: Delfilcon A

Interventions

Delfilcon ADEVICE

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

Also known as: Dailies Total 1
Delfilcon A

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2B 3K4, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Limitations and Caveats

The study was affected by the COVID-19 pandemic, which resulted in a mandated site closure to limit the spread of COVID-19.

Results Point of Contact

Title
Jill Woods
Organization
Centre for Ocular Research and Education
jwoods@uwaterloo.ca
5198884567

Study Officials

  • Lyndon Jones, PhD, FCOptom

    Centre for Ocular Research & Education

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 26, 2019

Study Start

September 23, 2019

Primary Completion

July 28, 2022

Study Completion

July 28, 2022

Last Updated

July 25, 2023

Results First Posted

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)