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The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A (A)/etafilcon A (B)/etafilcon A (C) | Other | Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear. |
|
| etafilcon A (A)/etafilcon A (C)/etafilcon A (B) | Other | Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear. |
|
| etafilcon A (C)/etafilcon A (A)/etafilcon A (B) | Other | Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear. |
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| etafilcon A (B)/etafilcon A (C)/etafilcon A (A) | Other | Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A (A) | Device | Daily wear contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit Acceptance | Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing. | 10-15 minutes post lens fit |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Snellen Visual Acuity (VA) | Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction. | 10-15 minutes post lens fit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cupertino | California | 95014 | United States | |||
Of those 95 enrolled subjects in this study, 3 did not meet the eligibility criteria, 6 prematurely discontinued from the study, and 6 excluded from the analysis due to protocol deviations.
This study was an eight-site, randomized, 4-visit, bilateral crossover, dispensing trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Subjects were to wear all three lenses over the course of the 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, 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 | Lens Fit Acceptance | Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing. | All subjects who successfully completed the study. | Posted | Number | eyes | 10-15 minutes post lens fit | Eyes | Eyes |
|
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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 | All Subjects | Subjects were to wear all three lenses over the course of the study. Due to the non-ocular related AE, all subjects are summarized to report the occurrence of event. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael S. Mayers, O.D., FAAO | Johnson & Johnson Vision Care | 1-904-443-3252 | MMayers@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 (C)/etafilcon A (B)/etafilcon A (A) | Other | Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear. |
|
| etafilcon A (B)/etafilcon A (A)/etafilcon A (C) | Other | Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear. |
|
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| etafilcon A (B) | Device | Daily wear contact lens |
|
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| etafilcon A (C) | Device | Daily wear contact lens |
|
|
| Corneal Staining |
Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis. |
| After 6-9 days of lens wear |
| Los Angeles |
| California |
| 90049 |
| United States |
| San Jose | California | 95131 | United States |
| Jacksonville | Florida | 32205 | United States |
| Jacksonville | Florida | 32256 | United States |
| Orlando | Florida | 32792 | United States |
| Adverse Event |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Binocular Snellen Visual Acuity (VA) | Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction. | All subjects who successfully completed the study. | Posted | Number | participants | 10-15 minutes post lens fit |
|
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| Secondary | Corneal Staining | Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis. | All subjects who successfully completed the study. | Posted | Number | eyes | After 6-9 days of lens wear | eye | eye |
|
|
|
| 1 |
| 95 |
| 0 |
| 95 |
Publication requires agreement and written authorization from the Sponsor
| Title | Measurements |
|---|---|
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| Nasal region grade > 0 |
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| Superior region grade > 0 |
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| Temporal region grade > 0 |
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