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The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.
The study will evaluate the daily wear performance of the Avaira (enfilcon A) spherical lens during two weeks of wear compared to Vistakon's Oasys (senofilcon A) spherical lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enfilcon A/senofilcon A | Active Comparator | Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks. |
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| senofilcon A/enfilcon A | Active Comparator | Subjects were randomized to wear senofilcon A then enfilcon A for two weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfilcon A | Device | enfilcon A daily wear soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort - First Intervention | Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt, | Baseline |
| Comfort - Second Intervention | Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt, | Baseline |
| Comfort - First Intervention | Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt). | 2 Weeks |
| Comfort - Second Intervention | Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt). | 2 Weeks |
| Comfortable Wearing Time - First Intervention | Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit. | 2 Weeks |
| Comfortable Wearing Time - Second Intervention | Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit. |
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Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
To be eligible to enter the study, subjects must have ALL of the inclusion criteria and NONE of the exclusion criteria present.
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| Name | Affiliation | Role |
|---|---|---|
| Don Siegel, OD | CooperVision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Eyecare | Pismo Beach | California | 93449 | United States | ||
| Eric M. White, OD, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enfilcon A, Then Senofilcon A | Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens |
| FG001 | Senofilcon A, Then Enfilcon A | Subjects were randomized to wear senofilcon A then enfilcon A for two weeks senofilcon A: senofilcon A daily wear soft contact lens enfilcon A: enfilcon A daily wear soft contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
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| Second Intervention (14 Days) |
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All subjects prior to dispense of first set of study lenses
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Group Prior to Dispense | All subjects prior to dispense of first set of study lenses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Comfort - First Intervention | Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt, | one drop out at first 2 week follow up | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
From dispense up to 2 weeks 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 | Enfilcon A/Senofilcon A | enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Don Siegel, OD | CooperVision, US | 623-544-3877 | dsiegel@coopervision.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| senofilcon A | Device | senofilcon A daily wear soft contact lens |
|
| 2 Weeks |
| San Diego |
| California |
| 92123 |
| United States |
| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | 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 | Comfort - Second Intervention | Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt, | one drop out at first 2 week follow up | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Comfort - First Intervention | Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt). | one drop out at first 2 week follow up | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| Primary | Comfort - Second Intervention | Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt). | 1 subject withdrew from study. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
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| Primary | Comfortable Wearing Time - First Intervention | Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit. | one drop out at first 2 week follow up | Posted | Mean | Standard Deviation | hours | 2 Weeks |
|
|
|
| Primary | Comfortable Wearing Time - Second Intervention | Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit. | one drop out at first 2 week follow up | Posted | Mean | Standard Deviation | hours | 2 Weeks |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Senofilcon A/Enfilcon A | senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens | 0 | 27 | 0 | 27 |
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor. Assuming that the product is marketed, it is the intention of the sponsor to publish the results of the study.
| 2 weeks wear |
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| Overall |
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| 2 weeks wear |
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| Overall |
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