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| Name | Class |
|---|---|
| Foresight Regulatory Strategies, Inc. | INDUSTRY |
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The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.
Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A toric / alphafilcon A toric | Other | senofilcon A toric contact lenses worn daily during the first period, then alphafilcon A toric contact lenses worn daily during the second period |
|
| alphafilcon A toric / senofilcon A toric | Other | alphafilcon A toric contact lenses worn daily during the first period, then senofilcon A toric contact lenses worn daily during the second period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A toric | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Reported Vision | A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision. | 1 week |
| Subject Reported Lens Comfort. | A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable. | 1 week |
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Inclusion Criteria: Prior to being considered eligible to participate in this study, subjects MUST
Exclusion Criteria:
The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
Slit lamp findings that would contraindicate contact lens wear such as:
A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
A known history of corneal hypoesthesia (reduced corneal sensitivity.)
Aphakia, keratoconus or a highly irregular cornea.
Current pregnancy or lactation (to the best of the subject's knowledge).
Active participation in another clinical study at any time during this study.
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| Name | Affiliation | Role |
|---|---|---|
| Jason Chin, O.D. | Principal Investigator | |
| James Fujimoto, O.D. | Principal Investigator | |
| Weslie Hamada, O.D. | Arthur T. Kobayashi, O.D., Inc. | Principal Investigator |
| Dennis Kuwuabara, O.D. | Eye Care Associates of Hawaii | Principal Investigator |
| Mark Nakano, O.D. | Mark E. Nakano Optometric Corp. | Principal Investigator |
| Ikuko Sugimoto, O.D. | Unaffilliated | Principal Investigator |
| Kevin Rosin, O.D. | Drs. Farkas, Kassalow, Resnick & Associates | Principal Investigator |
| Jennifer Kao, O.D. | Principal Investigator |
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Of those 96 enrolled subjects in the study, 7 did not meet the study eligibility criteria and 1 did not receive the study lenses. One enrolled subject was discontinued from the study leaving n=87 who completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A / Alphafilcon A | senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second |
| FG001 | Alphafilcon A / Senofilcon A | alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period |
| |||||||||||||
| Second Period |
|
Baseline summary was conducted on enrolled subjects who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Subjects who enrolled and completed 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 | Subjective Reported Vision | A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision. | Analysis includes only participants who completed the study per protocol and had no missing data. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | 1 week |
|
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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 | Senofilcon A | senofilcon A toric silicone hydrogel contact lenses worn |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD, FAAO | Vistakon | 904-443-3088 | kmoody1@its.jnj.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D001519 | Behavior |
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| alphafilcon A toric | Device | contact lens |
|
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Subject Reported Lens Comfort. | A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable. | Analysis includes only participants who completed the study per protocol and had no missing data. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | 1 week |
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Alphafilcon A | alphafilcon A toric hydrogel contact lenses worn | 0 | 96 | 0 | 96 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.