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This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O1D/P1 | Experimental | Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1) |
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| P1/O1D | Experimental | Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE Oasys 1-Day | Device | TEST |
| |
| Precision 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort (Phase I) | Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| End of Day Comfort (Phase I) | End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| End of Day Dryness (Phase I) | End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| End of Day Comfort (Phase II) | End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| End of Day Dryness (Phase II) | End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort Throughout the Day (Phase II) | Comfort Throughout the Day was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James R. Dugue Optometry | Mission Viejo | California | 92691 | United States | ||
| Maitland Vision Center |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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Phase I and Phase II are mutually exclusive. Data collected from Phase I was used to estimate the sample size requirements for Phase II primary endpoints.
This was a 2-Phase study. In Phase I, 75 subjects were enrolled. Of those enrolled into Phase I, all subjects were dispensed at least 1 study lens. Of those dispensed, 72 completed Phase I, while 3 subject discontinued. In Phase II, 227 subjects were enrolled. Of those enrolled, all subjects were dispensed at least 1 study lens. Of those dispensed in Phase II 206 completed the Phase II, while 21 subjects discontinued from Phase II.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A (C3)/Verofilcon A (Phase I) | Subjects randomized to this sequence received the senofilcon A (C3) lens during the first period and then received the verofilcon A lens during the second period. |
| FG001 | Verofilcon A/ Senofilcon A (C3) (Phase I) | verofilcon A/ senofilcon A (C3) (Phase I) Subjects randomized to this sequence received the verofilcon A lens during the first period and then received the senofilcon A (C3) lens during the second period. |
| FG002 | Senofilcon A (C3)/Verofilcon A (Phase II) | Subjects randomized to this sequence received the senofilcon A (C3) lens during the first period and then received the verofilcon A lens during the second period. |
| FG003 | Verofilcon A/ Senofilcon A (C3) (Phase II) | Subjects randomized to this sequence received the verofilcon A lens during the first period and then received the senofilcon A (C3) lens during the second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I- Period 1 |
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| Phase I- Period 2 |
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| Phase II- Period 1 |
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| Phase II -Period 2 |
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All subjects dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I | All subjects that were enrolled into Phase I of the study. |
| BG001 | Phase II | All subjects that were enrolled in Phase II of 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 | Overall Comfort (Phase I) | Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint. | Posted | Number | Number of responses | 1-Week Follow-up |
|
Throughout the entire duration of the study. Study duration for Phase I and Phase II were approximately 3-weeks per subject.
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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 | Phase I -Senofilcon A (C3) | Subjects that wore the senofilcon A (C3) lens in either the first or second period during Phase I of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross Franklin, BAppSc-Optom | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | RFRANKL1@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2021 | Oct 17, 2022 | Prot_SAP_000.pdf |
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| Device |
CONTROL |
|
| 1-Week Follow-up |
| Overall Comfort (Phase II) | Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| Comfort While Using Digital Devices (Phase II) | Comfort while Using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets)" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| Dryness While Using Digital Devices (Phase II) | Dryness while using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| Lens Awareness Upon Insertion (Phase II) | Lens Awareness Upon Insertion was assessed using the individual questionnaire item "I lost awareness of these lenses shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies. | 1-Minute Post lens fitting |
| Comfort Upon Insertion (Phase II) | Comfort Upon Insertion was assessed using the individual questionnaire item "These lenses were comfortable shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies. | 1-Minute Post lens fitting |
| Overall Ease of Handling (Phase II) | Overall Ease of Handling was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| Ease of Insertion (Phase II) | Ease of Insertion was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Ease of putting the lenses on your eyes " with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| Ease of Removal (Phase II) | Ease of Removal was assessed using the individual questionnaire item "how would you rate the study contact lenses on: Ease of taking the lenses off your eyes" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | 1-Week Follow-up |
| Maitland |
| Florida |
| 32751 |
| United States |
| Flora Chen Poveda, OD, PA | Orange Park | Florida | 32073 | United States |
| Visual Eyes, Inc | Roswell | Georgia | 30076 | United States |
| VisionPoint Center | Bloomington | Illinois | 61704 | United States |
| ABQ Eye Care | Albuquerque | New Mexico | 87109 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Optometry Group LLC | Memphis | Tennessee | 38111 | United States |
| Gulf Coast Vision Center, Inc. | Houston | Texas | 77054 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| Subject enrolled in error |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| 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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Subjects that wore the verofilcon A lens in either the first or second period of Phase I study.
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| Primary | End of Day Comfort (Phase I) | End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint. | Posted | Number | Number of responses | 1-Week Follow-up |
|
|
|
|
| Primary | End of Day Dryness (Phase I) | End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All Subjects that completed Phase I of the study without a major protocol deviation impacting a primary endpoint. | Posted | Number | Number of responses | 1-Week Follow-up |
|
|
|
|
| Primary | End of Day Comfort (Phase II) | End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
|
|
|
|
| Primary | End of Day Dryness (Phase II) | End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
|
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|
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| Primary | Overall Comfort (Phase II) | Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
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|
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| Secondary | Comfort Throughout the Day (Phase II) | Comfort Throughout the Day was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
|
|
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| Secondary | Comfort While Using Digital Devices (Phase II) | Comfort while Using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets)" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
|
|
|
| Secondary | Dryness While Using Digital Devices (Phase II) | Dryness while using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
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|
|
| Secondary | Lens Awareness Upon Insertion (Phase II) | Lens Awareness Upon Insertion was assessed using the individual questionnaire item "I lost awareness of these lenses shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Minute Post lens fitting |
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|
|
| Secondary | Comfort Upon Insertion (Phase II) | Comfort Upon Insertion was assessed using the individual questionnaire item "These lenses were comfortable shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Minute Post lens fitting |
|
|
|
| Secondary | Overall Ease of Handling (Phase II) | Overall Ease of Handling was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
|
|
|
| Secondary | Ease of Insertion (Phase II) | Ease of Insertion was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Ease of putting the lenses on your eyes " with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
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| Secondary | Ease of Removal (Phase II) | Ease of Removal was assessed using the individual questionnaire item "how would you rate the study contact lenses on: Ease of taking the lenses off your eyes" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies. | All subjects dispensed a study lens in Phase II with 1-week follow-up data for both study lenses. | Posted | Number | Number of responses | 1-Week Follow-up |
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|
| 0 |
| 73 |
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | Phase I -Verofilcon A | Subjects that wore the verofilcon A lens in either the first or second period during Phase I of the study. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG002 | Phase II -Senofilcon A (C3) | Subjects that wore the senofilcon A (C3) lens in either the first or second period during Phase II of the study. | 0 | 221 | 0 | 221 | 0 | 221 |
| EG003 | Phase II -Verofilcon A | Subjects that wore the verofilcon A lens in either the first or second period during Phase II of the study. | 0 | 220 | 0 | 220 | 0 | 220 |
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| Good |
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| Fair |
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| Poor |
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| Good |
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| Fair |
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| Poor |
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| Good |
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| Fair |
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| Poor |
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| Good |
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| Fair |
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| Poor |
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| Good |
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| Fair |
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| Poor |
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| Not Applicable |
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| Good |
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| Fair |
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| Poor |
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| Very Good |
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| Good |
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| Fair |
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| Poor |
|
| Very Good |
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| Good |
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| Fair |
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| Poor |
|
| Neither Agree nor Disagree |
|
| Agree |
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| Strongly Agree |
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| Neither Agree nor Disagree |
|
| Agree |
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| Strongly Agree |
|
| Very Good |
|
| Good |
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| Fair |
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| Poor |
|
| Very Good |
|
| Good |
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| Fair |
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| Poor |
|
| Very Good |
|
| Good |
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| Fair |
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| Poor |
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