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This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a total of 3 visits where all study endpoints will be measured in all subjects at baseline with habitual lenses and under the two testing treatments sequentially in separate visits based on the randomization scheme
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/SCR | Experimental | Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (TEST/SCR) sequentially |
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| SCR/TEST | Experimental | Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (SCR/TEST) sequentially |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | Acuvue Oasys 1-Day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (logMAR) | Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported. | 15 Minutes post Treatment Administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Contrast Sensitivity Function Curve | Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
Appear able and willing to adhere to the instructions set forth in this clinical protocol
Between 18 and 35 (inclusive) years of age at the time of screening
The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month)
The subject must meet all of the following three criteria:
The subject must have normal eyes (i.e., no ocular medications or infections of any type)
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRC East | Jacksonville | Florida | 32256 | United States |
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A total of 49 subjects were enrolled into this study. Of the enrolled subjects, 43 were dispensed at least one study article. Of the dispensed subjects all 43 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/SCR | Subjects that were randomized to receive the Test lens during the first period and then the SCR (Subjective Spherorcylindrical Refraction) treatment during the second period. |
| FG001 | SCR/Test | Subjects that were randomized to receive the SCR (Subjective Spherorcylindrical Refraction) treatment during the first period and then the Test lens during the second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Dispensed | All subjects dispensed at least one study treatment. |
| 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 | Visual Acuity (logMAR) | Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 15 Minutes post Treatment Administration | Eyes | Eyes |
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Throughout the entire duration of the study. Approximately 2 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 | Test | Subjects that received the Test lens during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chantal Coles-Brennan -PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care, INC. | 1-904-443-3449 | CColesb@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 | Jul 11, 2017 | Jul 26, 2018 | Prot_SAP_000.pdf |
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| Control |
| Device |
Trial Frame with best spherocylindrical refraction (SCR) |
|
| 15 minutes post treatment administration |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Count of Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Area Under Contrast Sensitivity Function Curve | Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. | All subjects who completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | log | 15 minutes post treatment administration | Eyes | Eyes |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | SCR (Subjective Spherorcylindrical Refraction) | Subjects that received the SCR treatment during either the first or second period of the study. | 0 | 43 | 0 | 43 | 0 | 43 |
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