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The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.
This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comfilcon A (test) | Active Comparator | Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. |
|
| Senofilcon C (control) | Active Comparator | Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comfilcon A (test) | Device | Daily wear contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Insertion(Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | Baseline |
| Ease of Insertion (Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | 2 weeks |
| Ease of Insertion(Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Rotational Recovery After Lens Mislocation | Lens relocation after 10 blinks, after 30º rotation mislocation | Baseline |
| Rotational Recovery After Lens Mislocation | Lens relocation after 10 blinks, after 30º rotation mislocation. |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD FCOptom | Director, Centre for Ocular Research and Education | 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 | Comfilcon A (Test) Then Senofilcon A (Control) | Participants were randomized to wear comfilcon A contact lenses first then or senofilcon C contact lenses bilaterally for one month during the cross-over study. Comfilcon A (test): Daily wear contact lenses Senofilcon C: Daily wear contact lenses |
| FG001 | Senofilcon C (Control) Then Comfilcon A (Test) | Participants were randomized to wear Senofilcon C control contact lenses first then Comfilcon A contact lenses bilaterally for one month during the cross-over study. Comfilcon A (test): Daily wear contact lenses Senofilcon C: Daily wear contact lenses |
| 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 | Ease of Insertion(Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
From baseline up to one month for each intervention.
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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 | Comfilcon A (Test) | Participants were randomized to wear comfilcon A contact lenses bilaterally for one month during the cross-over study. Comfilcon A (test): Daily wear contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc., FAAO | CooperVision,Inc. | 925 621 3761 | 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 | Jun 19, 2018 | May 22, 2020 | Prot_SAP_000.pdf |
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Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
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| Senofilcon C (control) | Device | Daily wear contact lenses |
|
| 1 month |
| NOT COMPLETED |
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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 |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Ease of Insertion (Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Ease of Insertion(Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
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| Secondary | Rotational Recovery After Lens Mislocation | Lens relocation after 10 blinks, after 30º rotation mislocation | Posted | Mean | Standard Deviation | Degrees | Baseline |
|
|
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| Secondary | Rotational Recovery After Lens Mislocation | Lens relocation after 10 blinks, after 30º rotation mislocation. | Posted | Mean | Standard Deviation | Degrees | 1 month |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Senofilcon C (Control) | Participants were randomized to wear Senofilcon C control contact lenses bilaterally for one month during the cross-over study. Senofilcon C: Daily wear contact lenses | 0 | 45 | 0 | 45 | 0 | 45 |
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