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This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.
This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A, Then Lens B | Experimental | Participants will wear Lens A for six hours and then cross over to wear Lens B for six hours. |
|
| Lens B, Then Lens A | Experimental | Participants will wear Lens B for six hours and then cross over to wear Lens A for six hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (comfilcon A lens) | Device | 6 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Lens Insertion | Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion) | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD,MCOptom | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | United Kingdom |
Thirty-eight participants attended the initial visit with all participants completing the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A, Then Lens B | Participants wore Lens A for 6 hours and then wore Lens B for 6 hours on two separate study days. |
| FG001 | Lens B, Then Lens A | Participants wore Lens B for 6 hours and then wore Lens A for 6 hours on two separate study days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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, 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 Lens Insertion | Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion) | Posted | Mean | Standard Deviation | units on a scale | 6 hours |
|
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From dispense up to six hours on each lens type, for a total of 12 hours
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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 six hours. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, 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 27, 2021 | Apr 12, 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 (lehfilcon A lens) |
| Device |
6 hours |
|
| Participants |
|
| 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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| Participants |
|
|
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Lens B | Participants wore Lens B for six hours. | 0 | 38 | 0 | 38 | 0 | 38 |
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