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The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.
This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enfilcon A | Experimental | participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye. |
|
| senofilcon A | Active Comparator | participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfilcon A | Device | Test lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort at Insertion | Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline. | Baseline |
| Comfort at Insertion | Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes. | 15 minutes |
| Comfort Preference | Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion. | Baseline |
| Comfort Preference | Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear. | 15 minutes |
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Inclusion Criteria:
Based on his/her knowledge, must be in good general health.
Be 18 to 38 years old.
Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
Read, indicate understanding of, and sign Written Informed Consent.
Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
Require a visual correction in both eyes.
Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Exclusion Criteria:
0.75D or greater of refractive astigmatism in either eye.
Presbyopic or current monovision contact lens wear.
Cannot be currently wearing either lenses (Avaira or Oasys).
Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.
Aphakia, Keratoconus or a highly irregular cornea.
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| Name | Affiliation | Role |
|---|---|---|
| Donald Siegel, OD | CooperVision, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schaeffer Eye Associates | Birmingham | Alabama | 35216 | United States | ||
| Beaches Family Eyecare |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enfilcon A | participants randomized to wear the (enfilcon A) test lens in one eye. Enfilcon A: contact lens |
| FG001 | Senofilcon A | participants randomized to wear the senofilcon A contact lens (control) in the one eye. Senofilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Group | participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye. |
| 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 | Comfort at Insertion | Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline | eyes | eyes |
|
From dispense up to 15 minutes for both study lenses.
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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 | participants randomized to wear the test lens (enfilcon A) in one eye. Enfilcon A: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald Siegel, OD | CooperVision | 602 485 3414 | dsiegel@coopervision.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| senofilcon A |
| Device |
Control lens |
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Todays Eyecare, LLC | Lafayette | Louisiana | 70503 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| eyes |
|
|
| Primary | Comfort at Insertion | Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes | Eyes | Eyes |
|
|
|
| Primary | Comfort Preference | Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion. | n=59, one participant would not choose a preference at the initial insertion as both lenses were the same to them. | Posted | Number | participants | Baseline |
|
|
|
| Primary | Comfort Preference | Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear. | Posted | Number | participants | 15 minutes |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Senofilcon A | participants randomized to wear the control lens (senofilcon A) in the one eye. Senofilcon A: contact lens | 0 | 60 | 0 | 60 | 0 | 60 |
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