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To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A, Then Lens B | Experimental | Participants wore Lens A for one month and then crossed over to wear Lens B for one month. |
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| Lens B, Then Lens A | Experimental | Participants wore Lens B for one month and then crossed over to wear Lens A for one month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (lehfilcon A lens) | Device | Daily wear for 1 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling on Lens Removal | Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied) | 1 month |
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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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry & Vision Science | Waterloo | N2L 3G1 | Canada |
There were 27 people screened and 26 were dispensed with study products. Two participants discontinued and 24 completed the study.
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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. Each Lens type was worn on a daily wear basis 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. Each Lens type was worn on a daily wear basis for one month. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Analysis Population | Out of 26 participants, 2 of them discontinued. Therefore, overall base participants (Analysis population) are 24. |
| 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 | Lens Handling on Lens Removal | Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied) | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
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From dispense up to one month on each study lens, for total of two months
Enrollment population (n=26)
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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 1 month. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Significant Ocular Redness | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, MSc, FAAO | CooperVision | 9256213761 | 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 | Mar 28, 2022 | Sep 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B (comfilcon A lens) | Device | Daily wear for 1 month. |
|
| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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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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|
|
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Lens B | Participants wore Lens B for 1 month. | 0 | 26 | 0 | 26 | 1 | 26 |
| asymptomatic corneal infiltrate keratitis | Eye disorders | Systematic Assessment |
|
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