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The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.
The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A | Experimental | Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week. |
|
| etafilcon A | Active Comparator | Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A | Device | Contact Lens |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 1 |
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 3 |
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 5 |
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | 1 Week |
| Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 1 |
| Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 3 |
| Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration | Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive & occasionally encroaching limbus) | Baseline (after 10 minutes of lens fitting) |
| Lens Centration |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Baseline |
| Subjective Ratings of Comfort After Lens Insertion |
Inclusion Criteria:
Subjects will only be eligible for the study 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;
Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
Demonstrates an acceptable fit with the study lenses;
Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Somofilcon A Then Etafilcon A | Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week. somofilcon A: Contact Lens etafilcon A: Contact Lens |
| FG001 | Etafilcon A Then Somofilcon A | Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. etafilcon A: Contact Lens somofilcon A: Contact Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total Participants |
| 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 | Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
From baseline till 1 -week for each type of lenses, up to 2 weeks total
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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 | Somofilcon A | Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. somofilcon A: Contact Lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjuctival Staining | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@coopervision.com |
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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 | Oct 2, 2019 | Jul 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A | Device | Contact Lens |
|
|
| Lens Handling for Lens Removal |
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) |
| 1 week |
Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive & occasionally encroaching limbus) |
| 1 week |
| Post-blink Movement | Post-blink movement in primary gaze, in 0.1mm steps | Baseline (after 10 minutes of lens fitting) |
| Post-blink Movement | Post-blink movement in primary gaze, in 0.1mm steps | 1 -week |
| Push-up Tightness | Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | Baseline (after 10 minutes of lens fitting) |
| Push-up Tightness | Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | 1 week |
Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
| 1 Day |
| Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Day 3 |
| Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Day 5 |
| Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | 1-Week |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | Day 3 |
|
|
|
| Primary | Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | Day 5 |
|
|
|
| Primary | Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | 1 Week |
|
|
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| Primary | Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| Primary | Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | Day 3 |
|
|
|
| Primary | Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | Day 5 |
|
|
|
| Primary | Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Lens Centration | Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive & occasionally encroaching limbus) | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 10 minutes of lens fitting) |
|
|
|
| Secondary | Lens Centration | Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive & occasionally encroaching limbus) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Post-blink Movement | Post-blink movement in primary gaze, in 0.1mm steps | Posted | Mean | Standard Deviation | millimeters | Baseline (after 10 minutes of lens fitting) |
|
|
|
| Secondary | Post-blink Movement | Post-blink movement in primary gaze, in 0.1mm steps | Posted | Mean | Standard Deviation | millimeters | 1 -week |
|
|
|
| Secondary | Push-up Tightness | Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 10 minutes of lens fitting) |
|
|
|
| Secondary | Push-up Tightness | Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Posted | Mean | Standard Deviation | units on a scale | 1 Day |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Posted | Mean | Standard Deviation | units on a scale | Day 3 |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Posted | Mean | Standard Deviation | units on a scale | Day 5 |
|
|
|
| Other Pre-specified | Subjective Ratings of Comfort After Lens Insertion | Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses). | Posted | Mean | Standard Deviation | units on a scale | 1-Week |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 2 |
| 55 |
| EG001 | Etafilcon A | Subjects will be randomized to wear etafilcon A daily disposable lenses for one week. etafilcon A: Contact Lens | 0 | 55 | 0 | 55 | 0 | 55 |
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