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This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delefilcon A/ Etafilcon A | Experimental | 6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear |
|
| Etafilcon A / Delefilcon A | Experimental | 6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delefilcon A | Device | Daily wear soft contact lens for bilateral distance vision correction use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Ease of Removal | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit. | 6-10 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Overall Comfort | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit. | 6-10 Days |
| Subject Reported Overall Vision |
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Inclusion Criteria:
The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week.
The subject must be a current successful soft contact lens wearer in both eyes
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye.
The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.
The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
The subject must require a visual correction in both eyes (no monofit or monovision allowed).
The subject must 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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72116 | United States | |||
There were 183 subjects enrolled with 183 subjects randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A \ Etafilcon A | 6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use. etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use. |
| FG001 | Etafilcon A \ Delefilcon A | 6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use. etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| ||||||||||||||||||
| Period 2 |
|
All enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Subject Reported Ease of Removal | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit. | Subjects analyzed were those who enrolled, randomized, and completed the study per protocol. | Posted | Number | percentage of participants | 6-10 Days |
|
Throughout the duration of the study. Approximately 2 weeks.
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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 | Delefilcon A | Subjects that received the delefilcon A lens in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist | Vistakon | 904 443-1032 | kosborn@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A | Device | Daily wear soft contact lens for bilateral distance vision correction use. |
|
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit. |
| 6-10 Days |
| Binocular Snellen Visual Acuity | Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye. | 6-10 Days |
| Overall Corneal Staining | Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye. Grade 1 or higher is reported as a percentage of total eyes. | 6-10 Days |
| Bridgeport |
| Connecticut |
| 06610 |
| United States |
| Tampa | Florida | 33625 | United States |
| Blue Springs | Missouri | 64015 | United States |
| Vestal | New York | 13850 | United States |
| Raleigh | North Carolina | 27615 | United States |
| Kittanning | Pennsylvania | 16201 | United States |
| Warwick | Rhode Island | 02888 | United States |
| Chamberlain | South Dakota | 57325 | United States |
| Bartlett | Tennessee | 38134 | United States |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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|
| Secondary | Subject Reported Overall Comfort | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit. | Posted | Number | percentage of participants | 6-10 Days |
|
|
|
| Secondary | Subject Reported Overall Vision | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit. | Posted | Number | percentage of participants | 6-10 Days |
|
|
|
| Secondary | Binocular Snellen Visual Acuity | Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye. | Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only. | Posted | Number | percentage of eyes | 6-10 Days | Eyes | Eyes |
|
|
|
| Secondary | Overall Corneal Staining | Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye. Grade 1 or higher is reported as a percentage of total eyes. | Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes. | Posted | Number | percentage of eyes | 6-10 Days | eyes | eyes |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | Etafilcon A | Subjects that received the delefilcon A lens in either the first or second period of the study. | 0 | 90 | 0 | 90 |
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