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Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses
Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyDay Toric | Experimental | Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study |
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| 1-Day Acuvue Moist for Astigmatism | Active Comparator | Participants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study |
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| Dailies Aquacomfort Plus Toric | Active Comparator | Participants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dailies Aquacomfort Plus Toric | Device | daily disposable contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses. | 1 week |
| Dryness | Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness | 1 week |
| Visual Quality | Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied | 1 week |
| Lens Preference With Respect to Overall Comfort | Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference | 1 week |
| Lens Preference With Respect to Visual Quality | Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference | 1 week |
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Inclusion Criteria:
Is at least 17 years of age and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer;
Is willing to wear contact lens in both eyes for the duration of the study;
Has a minimum spectacle astigmatism of - 0.75;
Can be fit with the three study contact lens types in the powers available;
Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity);
Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses.
Has clear corneas and no active* ocular disease;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCLR, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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60 subjects were enrolled for this study (assigned a subjectID), but 11 of these subjects were screen failures, leaving 49 subjects who were randomized for lens assignments.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Day AM First, Then DACP, Then MDT | 1-day Acuvue Moist for Astig first, then Dailies Aquacomfort Plus, then MyDay Troic |
| FG001 | 1-Day AM First, Then MDT, Then DACP | 1-day Acuvue Moist for Astig, then MyDay Toric, then Dailies Aquacomfort Plus |
| FG002 | DACP First, Then 1-Day AM, Then MDT | Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig, then MyDay Toric |
| FG003 | DACP First, Then MDT, Then 1-Day AM | Dailies Aquacomfort Plus, then MyDay Toric, then 1-day Acuvue Moist for Astig |
| FG004 | MDT First, Then 1-Day AM, Then DACP | MyDay Toric, then 1-day Acuvue Moist for Astig, then Dailies Aquacomfort Plus |
| FG005 | MDT First, Then DACP, Then 1-Day AM | MyDay Toric, then Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 |
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| Week 2 |
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| Week 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | A bilateral dispensing of MyDay Toric, 1-Day Acuvue Moist for Astigmatism, and Dailies Aqua Comfort Plus Toric Contact Lenses |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Comfort | Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses. | Posted | Median | Standard Deviation | units on a scale | 1 week |
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Adverse events were collected during the 3 week study duration.
Adverse event information was routinely collected during the weekly visits over the study duration or self-reported by the subjects if event was realized outside of visits.
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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 | MyDay Toric | Participants who wore MyDay Toric contact lenses | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A.Vega OD MSc., FAAO | CooperVision | 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 14, 2016 | Aug 27, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 1-Day Acuvue Moist for Astigmatism | Device | daily disposable contact lens |
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| MyDay Toric | Device | daily disposable contact lens |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Dailies Aquacomfort Plus Toric Contact Lens |
Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study. |
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| Primary | Dryness | Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness | Posted | Median | Standard Deviation | units on a scale | 1 week |
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| Primary | Visual Quality | Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied | Posted | Median | Standard Deviation | units on a scale | 1 week |
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| Primary | Lens Preference With Respect to Overall Comfort | Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference | Posted | Count of Participants | Participants | 1 week |
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| Primary | Lens Preference With Respect to Visual Quality | Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference | Posted | Count of Participants | Participants | 1 week |
|
|
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| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 1-Day Acuvue Moist for Astigmatism | Participants who wore 1-Day Acuvue Moist for Astigmatism contact lenses | 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | Dailies Aqua Comfort Plus Toric | Participants who wore Dailies Aqua Comfort Plus Toric contact lenses | 0 | 49 | 0 | 49 | 0 | 49 |
Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
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| Slightly Prefer 1Day Acuvue Moist Toric |
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| Strongly Prefer Dailies Aquacomfort Plus Toric |
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| Slighlty Prefer Dailies Aquacomfort Plus Toric |
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| No Preference |
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| Slightly Prefer 1Day Acuvue Moist Toric |
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| Strongly Prefer Dailies Aquacomfort Plus Toric |
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| Slightly Prefer Dailies Aquacomfort Plus Toric |
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| No Preference |
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