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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 and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.
Non-dispensing, single-masked (subject-masked), randomised, controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A/alphafilcon A/etafilcon A | Active Comparator | First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses |
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| alphafilcon A/etafilcon A/senofilcon A | Active Comparator | First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses |
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| etafilcon A/senofilcon A/alphafilcon A | Active Comparator | First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses |
|
| senofilcon A/etafilcon A/alphafilcon A | Active Comparator | First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A toric contact lens | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Number of eyes with Distance Visual Acuity 20/20 or better | 15-20 minutes |
| Patient Reported Vision | A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision. | 15-20 minutes |
| Lens Orientation Within 5 Degrees | Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation. | 1 minute |
| Lens Stability Within 5 Degrees | Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation. | 1 minute |
| Patient Reported Comfort. | A weighted combined score 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 difference in outcome between the test and control. >0=comfortable, <0=uncomfortable | 15-20 minutes |
| Patient Preference | This outcome measures which lens the subjects preferred to wear. | end of study |
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Inclusion Criteria:
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, OlD. | 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. | Principal Investigator | |
| Kevin Rosin, O.D. | Drs. Farkas, Kassalow, Resnick & Associates | Principal Investigator |
| Jennifer Kao, O.D. | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/Alphafilcon A/Etafilcon A | First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses |
| FG001 | Alphafilcon A/Etafilcon A/Senofilcon A | First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses |
| FG002 | Etafilcon A/Senofilcon A/Alphafilcon A | First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses |
| FG003 | Senofilcon A/Etafilcon A/Alphafilcon A | First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses |
| FG004 | Alphafilcon A/Senofilcon A/Etafilcon A | First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere |
| FG005 | Etafilcon A/Alphafilcon A/Senofilcon A | First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Completed Population | Only participants that completed the study are included (n=88) |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Visual Acuity | Number of eyes with Distance Visual Acuity 20/20 or better | Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes) | Posted | Number | Eyes with Snellen VA 20/20 or better | 15-20 minutes |
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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/Alphafilcon A/Etafilcon A | First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD, FAAO | Vistakon | 904-443-3088 |
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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/senofilcon A/etafilcon A | Active Comparator | First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses |
|
| etafilcon A/alphafilcon A/senofilcon A | Active Comparator | First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses |
|
| alphafilcon A toric | Device | contact lens |
|
| etafilcon A sphere | Device | contact lens |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Patient Reported Vision | A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision. | Analysis includes participants who completed the study per protocol (n=88) | Posted | Least Squares Mean | Standard Error | Scores on a scale | 15-20 minutes |
|
|
|
|
| Primary | Lens Orientation Within 5 Degrees | Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation. | Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes) | Posted | Number | degrees | 1 minute |
|
|
|
|
| Primary | Lens Stability Within 5 Degrees | Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation. | Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes) | Posted | Number | degrees | 1 minute |
|
|
|
|
| Primary | Patient Reported Comfort. | A weighted combined score 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 difference in outcome between the test and control. >0=comfortable, <0=uncomfortable | Analysis includes participants who completed the study per protocol (n=88) | Posted | Least Squares Mean | Standard Error | Scores on a scale | 15-20 minutes |
|
|
|
|
| Primary | Patient Preference | This outcome measures which lens the subjects preferred to wear. | Analysis includes participants who completed the study per protocol (n=88) | Posted | Number | Number of participants | end of study |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Alphafilcon A/Etafilcon A/Senofilcon A | First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses | 0 | 17 | 0 | 17 |
| EG002 | Etafilcon A/Senofilcon A/Alphafilcon A | First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses | 0 | 16 | 0 | 16 |
| EG003 | Senofilcon A/Etafilcon A/Alphafilcon A | First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses | 0 | 14 | 0 | 14 |
| EG004 | Alphafilcon A/Senofilcon A/Etafilcon A | First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere | 0 | 16 | 0 | 16 |
| EG005 | Etafilcon A/Alphafilcon A/Senofilcon A | First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses | 0 | 16 | 0 | 16 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.