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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.
This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A, Then Lens B | Experimental | Participants will wear lens A for one month and then cross over to wear lens B for one month. |
|
| Lens B, Then Lens A | Experimental | Participants will wear lens B for one month and then cross over to wear lens A for one month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (comfilcon A lens) | Device | 1 month |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings on Lens Handling on Removal | Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult) | Day 27 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wilkinson | Spadina Optometry | Principal Investigator |
| Roxanne Achong-Coan | Coan Eyecare | Principal Investigator |
| Fiona Soong | Eyes on Sheppard Clinic | Principal Investigator |
| Mike Cymbor | Nittany Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coan Eye Care | Ocoee | Florida | 34761 | United States | ||
| Nittany Eye Associate |
Sixty-seven participants were screened with no screen failures. One participant discontinued and the remaining 66 all completed the study.
All the participants who completed the study were included in the analysis. (Analysis population n=66)
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A, Then Lens B | Participants wore Lens A for one month and then crossed over to wear Lens B for one month. |
| FG001 | Lens B, Then Lens A | Participants wore Lens B for one month and then crossed over to wear Lens A for one month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Second Intervention |
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Sixty-six participants completed the study, and demographic data include all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Analysis Population | Sixty-six participants completed the study, and demographic data include all participants who completed the study. |
| 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 Ratings on Lens Handling on Removal | Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult) | Participants | Posted | Mean | Standard Deviation | Units on scale | Day 27 |
|
|
From dispense up to one month on each study lens, for total of two months
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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 | Lens A | Participants wore Lens A for one month | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A Vega, OD, MSc, FAAO | CooperVision | 9256213761 | javega2@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 | Nov 17, 2021 | Jun 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Lens B (lehfilcon A lens) |
| Device |
1 month |
|
| State College |
| Pennsylvania |
| 168801 |
| United States |
| Eyes on Sheppard Clinic | Toronto | Ontario | M2N 3A4 | Canada |
| Spadina Optometry | Toronto | Ontario | M5V 3E7 | Canada |
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| 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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| Counts |
|---|
| Participants |
|
|
| 66 |
| 0 |
| 66 |
| 4 |
| 66 |
| EG001 | Lens B | Participants wore Lens B for one month | 0 | 66 | 0 | 66 | 2 | 66 |
| Lens discomfort | Product Issues | Systematic Assessment |
|
| Sinus | Infections and infestations | Systematic Assessment |
|
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