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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delfilcon A | Experimental | All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delfilcon A | Device | Participants wear delafilcon A contact lenses on a daily disposable basis. |
|
| 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). |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD, FCOptom | Centre for Ocular Research & Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | N2B 3K4 | Canada |
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Out of 40 participants enrolled, 37 met the inclusion criteria.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A | All study participants will be refit with Delefilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delefilcon A: Participants wear delefilcon A contact lenses on a daily disposable basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Full Range | score on a scale | Day 1 after screening with habitual lenses |
|
|
Up to 35-48 days
Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ocular Adverse Events Only: Habitual Contact Lenses | All study participants will wear their habitual daily disposable contact lenses for 6-14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stye | Eye disorders | Systematic Assessment |
The study was affected by the COVID-19 pandemic, which resulted in a mandated site closure to limit the spread of COVID-19.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Woods | Centre for Ocular Research and Education | 5198884567 | 36743 | jwoods@uwaterloo.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2019 | Mar 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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
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| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 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). | Posted | Median | Full Range | score on a scale | 1-month follow up with delefilcon A |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 1 after screening with habitual lenses |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 3 after screening with habitual lenses |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 5 after screening with habitual lenses |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | 1-week follow up with habitual lens |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 1 after dispense with delefilcon A |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 3 after dispense with delefilcon A |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 5 after dispense with delefilcon A |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 7 after dispense with delefilcon A |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 21 after dispense with delefilcon A |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | Day 28 after dispense with delefilcon A |
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| Primary | Average Lens Wear Time | Average lens wear time is recorded | Posted | Median | Full Range | hours per day | 1-month follow up with delefilcon A |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 1 after screening with habitual lenses |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 3 after screening with habitual lenses |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 5 after screening with habitual lenses |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | 1-week follow up with habitual lens |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 1 after dispense with delefilcon A |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 3 after dispense with delefilcon A |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 5 after dispense with delefilcon A |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 7 after dispense with delefilcon A |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 21 after dispense with delefilcon A |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | Day 28 after dispense with delefilcon A |
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| Primary | Comfortable Lens Wear Time | Comfortable lens wear time (Time of discomfort - Time of insertion) | Posted | Median | Full Range | hours per day | 1-month follow up with delefilcon A |
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|
| 0 |
| 37 |
| 0 |
| 37 |
| 1 |
| 37 |
| EG001 | Ocular Adverse Events Only: Delefilcon A | All study participants will be refit with Delefilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delefilcon A: Participants wear delefilcon A contact lenses on a daily disposable basis. | 0 | 35 | 0 | 35 | 1 | 35 |
| EG002 | Systemic Adverse Events: Habitual Contact Lenses | All study participants will wear their habitual daily disposable contact lenses for 6-14 days. | 0 | 37 | 0 | 37 | 0 | 37 |
| EG003 | Systemic Adverse Events: Delefilcon A | All study participants will be refit with Delefilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delefilcon A: Participants wear delefilcon A contact lenses on a daily disposable basis | 0 | 35 | 0 | 35 | 0 | 35 |
| Cyst | Eye disorders | Systematic Assessment | Asymptomatic raised spot in left lower lid. |
|
| Foreign body trail | Eye disorders | Systematic Assessment | Foreign body trail on cornea (epithelium). |
|
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