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Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prototype toric lens senofilcon A | Experimental | Subjects will wear the senofilcon A prototype toric contact lens bilaterally for 6-8 days as a daily disposable modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype toric lens senofilcon A | Device | Investigational prototype |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eyes With Monocular Visual Acuity Better Than 20/40 | Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported. | 7 day follow-up |
| The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported. | 15 Minutes Post Insertion |
| Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees | Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported. | 15 Minutes Post Insertion |
| Proportion of Subject Eyes With Acceptable Lens Fit | Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported. | 15 Minute Post Insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward S. Wygonik, OD | Jacksonville | Florida | 32250 | United States | ||
| The Eye Center |
A total of 177 subjects were enrolled into this study. Of the enrolled subjects, 7 did not meet the eligibility criteria and 170 subjects were dispensed a study lens. Of the dispensed subjects, 7 were discontinued and 163 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prototype Toric Lens Senofilcon A | All subjects in this study were dispensed the prototype toric lens senofilcon A in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pembroke Pines |
| Florida |
| 33024 |
| United States |
| Eye Associates of Winter Park | Winter Park | Florida | 32792 | United States |
| Eyecare Associates | Bloomington | Illinois | 61701 | United States |
| Indiana University College of Optometry | Bloomington | Indiana | 47405 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| ABQ Eyecare | Albuquerque | New Mexico | 87109 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| New Image Eye Center | Springfield | Ohio | 45503 | United States |
| Professional Vision Care | Westerville | Ohio | 43081 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prototype Toric Lens Senofilcon A | All subjects in this study were dispensed the prototype toric lens senofilcon A in this study. |
| 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 | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Proportion of Eyes With Monocular Visual Acuity Better Than 20/40 | Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation. | Posted | Number | proportion of Subject Eyes | 7 day follow-up | Subject Eyes | Subject Eyes |
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| Primary | The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation. | Posted | Number | proportion of Subject Eyes | 15 Minutes Post Insertion | Subject Eyes | Subject Eyes |
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| Primary | Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees | Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation. | Posted | Number | proportion of Subject Eyes | 15 Minutes Post Insertion | Subject Eyes | Subject Eyes |
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| Primary | Proportion of Subject Eyes With Acceptable Lens Fit | Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation. | Posted | Number | proportion of Subject Eyes | 15 Minute Post Insertion | Subject Eyes | Subject Eyes |
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Throughout the duration of the study- approximately 2 months
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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 | Prototype Toric Lens Senofilcon A | All subjects in this study were dispensed the prototype toric lens senofilcon A in this study. | 0 | 170 | 0 | 170 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Straker, BAppSc(Optom)(HonS) Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 1380 | Bstraker@ITS.JNJ.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Subject Eyes |
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| Subject Eyes |
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| Subject Eyes |
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