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The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for one 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 (0-10 scale, 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 |
|---|---|---|
| Lyndon Jones, PhD FCOptom | Centre for Ocular Research and Education | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States | ||
| Sacco Eye Group |
Sixty-six participants were screened. Of the 66 that were dispensed with lenses, two were discontinued.
One of the completing participants presented at the final visit wearing an unknown lens. It was decided to exclude all the data for this participant and this finding was reported as a major protocol deviation. All remaining participants who completed the study were included in the analysis (Analysis population n=63).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens B, Then Lens A | Participants wore Lens B for one month and then crossed over to wear Lens A for one month. |
| FG001 | Lens A, Then Lens B | Participants wore Lens A for one month and then crossed over to wear Lens B for one month. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Second Intervention |
|
Sixty-six participants were screened, and demographic data include all screened participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total study population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult) | Posted | Mean | Standard Deviation | units on a scale | Day 27 |
|
|
From dispense up to one month on each study lens, for a 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 | |
|---|---|---|---|---|
| José A. Vega, O.D., MSc., FAAO | CooperVision | 925-621-3761 | JVega2@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 | Sep 30, 2021 | Mar 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B (lehfilcon A lens) |
| Device |
1 month |
|
| Vestal |
| New York |
| 13850 |
| United States |
| Athens Eye Care | Athens | Ohio | 45701 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| NOT COMPLETED |
|
| 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 |
|
|
|
| 66 |
| 0 |
| 66 |
| 3 |
| 66 |
| EG001 | Lens B | Participants wore Lens B for one month. | 0 | 66 | 0 | 66 | 2 | 66 |
| Sinus infection | Infections and infestations | Systematic Assessment |
|
| Single infiltrate in superior cornea | Eye disorders | Systematic Assessment |
|
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