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This clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Experimental | Eligible subjects that are habitual spectacle wearers will use their habitual optical correction and undergo ocular evaluations and questionnaires at the baseline and 1-week visit. |
|
| Interventional | Experimental | Eligible subjects that are habitual contact lens wearers who own spectacles will be randomized into 1 of 2 sequences (Spectacle/ACUVUE OASYS 1-Day or ACUVUE OASYS 1-Day/Spectacle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacles | Device | Subjects' own habitual spectacles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT) | NIBUT/NIKBUT was measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. NIBUT is measured by a topographer (e.g. Medmont) via observation by the investigator and a stopwatch. NIKBUTis measured by the Oculus Keratograph and reported by the instrument. Different instrumentation was used depending on site availability. Combined measurements of pre-lens data collected for the interventional arm are reported. Only the interventional arm was reported since the primary analysis was conducted among habitual contact lens users. The average NIKBUT was reported for each treatment. Higher values indicate better performance | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Total Scores of Meibomian Gland Expressibility (MGE) | Meibomian gland expressiblity was assessed in three regions of the lower eyelid: temporal, central, and nasal. Each region is expressed and the overall grade of the region is evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. The total score was calculated as the sum of all grades across the three regions and ranged from 0 (no secretion) to 9, with higher scores indicating more MGE. Total scores were converted into a binary variable for the analysis purpose where Y=1 if the total score is greater than 6 and 0 otherwise. The percentage of participants with MGE total score greater than 6 was estimated. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject will have completed the pre-screening Classification questionnaire.
Subject must have a working cell phone capable of sending and receiving text messages.
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 42 (inclusive) years of age at the time of screening
Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week wear time over the last 1 month by self-report OR be a full-time spectacle wearer (7 days/ week) without contact lens wear over the last 6 months.
Subjects must be willing to adhere to spectacle-only refractive correction for approximately 1 week.
Subjects must possess a functional / usable pair of spectacles with which they can achieve 20/20 Snellen visual acuity or better at distance and near, and bring them to the visit
The subject's vertex corrected spherical distance refraction must be in the range (+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye.
The subject's vertex corrected refractive cylinder must be equal or less than -0.75 diopters in each eye.
Contact lens wearers must have spherical best corrected visual acuity of 20/25 or better in each eye.
Snellen visual acuity at distance and near must be within 1 line between subject's own spectacle and the manifest refraction, distance and near, OD & OS.
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 | ||
| Sabal Eye Care |
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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Of the 21 subjects assigned to the observational arm, all subjects completed the study. Of the 44 subjects assigned to the interventional arm 2 subjects were discontinued. A total of 63 subjects completed the study.
A total of 78 subjects were enrolled into this study. Of those enrolled, 65 subjects were assigned to either the observational arm (21) or the interventional arm (44), while 13 subjects failed to meet all eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational | Participants wearing their habitual spectacle wearers during the course of the study. This arm was included in the study to investigate ocular characteristics among habitual spectacle wearers which served as a reference group. |
| FG001 | Interventional: Test (Senofilcon A)/Control (Spectacle) | Subjects randomized to this sequence received the Test lens (senofilcon A) during the first period and then worn their spectacles (Control) during the second period. |
| FG002 | Interventional: Control (Spectacle)/Test (Senofilcon A) | Subjects randomized to this sequence worn their spectacles (Control) during the first period and then received the Test lens (senofilcon A) during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
|
All subjects who were assigned either to the interventional arm or the observational arm based on their habitual vision corrections.
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Arm | Subjects wearing their habitual spectacle wearers during the course of the study. This arm was included in the study to investigate ocular characteristics among habitual spectacle wearers which served as a reference group. |
| BG001 | Interventional Arms |
| 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 | Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT) | NIBUT/NIKBUT was measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. NIBUT is measured by a topographer (e.g. Medmont) via observation by the investigator and a stopwatch. NIKBUTis measured by the Oculus Keratograph and reported by the instrument. Different instrumentation was used depending on site availability. Combined measurements of pre-lens data collected for the interventional arm are reported. Only the interventional arm was reported since the primary analysis was conducted among habitual contact lens users. The average NIKBUT was reported for each treatment. Higher values indicate better performance | All subjects who had successfully completed all visits in the interventional arm and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Seconds | 1-Week Follow-up | eyes | eyes |
|
Throughout the duration of the study (about 3 weeks for subjects in the interventional arm and about 1 week for subjects in the observational arm).
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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 | Observational | Participants wearing their habitual spectacle wearers during the course of the study. This arm was included in the study to investigate ocular characteristics among habitual spectacle wearers which served as a reference group. |
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No study limitations were reported for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Dow, PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care | +1800-843-2020 | edow1@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 | Apr 16, 2019 | Jun 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| ACUVUE OASYS®1-Day with HydraLuxe™ Technology |
| Device |
Test 1 |
|
| 1-Week Follow-up |
| Conjunctival Staining | Conjunctival staining was graded and recorded by quadrant (Superior, Inferior, Nasal, and Temporal) using the following grading scale: Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate, and Grade 4 = Severe. Average grade was calculated based on grades of the four quadrants. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users. | 1-Week Follow-up |
| Number of Eyes With Clinically Significant (Grade 3 or 4 of Overall Classification) Lid Wiper Epitheliopathy | Horizontal lid margin staining and sagittal lid margin staining are graded for each eyelid (upper and lower) separately. The horizontal and sagittal grades are then averaged for each eyelid to obtain the upper lid average grade and lower lid average grade. The final grade is the average of the upper and lower lid average grades. Participants can be classified according to their final grades for each eye. The classification is defined as follows: "None" for final grades of 0, "Mild" for final grades between 0.25 and 1.00, "Moderate" for final grades between 1.25 and 2.00, and "Severe" for final graded between 2.25 and 3.00. Only the interventional arm was reported since the secondary analysis was planned to be conducted among habitual contact lens users only. | 1-Week Follow-up |
| Meibomian Gland Expressibility (MGE) Grades | Meibomian gland expressiblity was assessed in three regions of the lower eyelid: temporal, central, and nasal. Each region is expressed and the overall grade of the region is evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users. | 1-Week Follow-up |
| Longwood |
| Florida |
| 32779 |
| United States |
| Manhattan Vision Associates | New York | New York | 10022 | United States |
| NOT COMPLETED |
|
Participants assigned to the interentional arm to wear the Test lens and their own spectacles in a random order. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| Test (Senofilcon A) |
Subjects that wore the Test article in either the first or second period of the study. |
| OG001 | Control (Spectacle) | Subjects that wore their spectacles in either the first or second period of the study. |
|
|
|
| Secondary | Total Scores of Meibomian Gland Expressibility (MGE) | Meibomian gland expressiblity was assessed in three regions of the lower eyelid: temporal, central, and nasal. Each region is expressed and the overall grade of the region is evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. The total score was calculated as the sum of all grades across the three regions and ranged from 0 (no secretion) to 9, with higher scores indicating more MGE. Total scores were converted into a binary variable for the analysis purpose where Y=1 if the total score is greater than 6 and 0 otherwise. The percentage of participants with MGE total score greater than 6 was estimated. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users. | All participants who had successfully completed all visits in the interventional arm and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up | Eyes | Eyes |
|
|
|
|
| Secondary | Conjunctival Staining | Conjunctival staining was graded and recorded by quadrant (Superior, Inferior, Nasal, and Temporal) using the following grading scale: Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate, and Grade 4 = Severe. Average grade was calculated based on grades of the four quadrants. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users. | All subjects who had successfully completed all visits in the interventional arm and did not substantially deviate from the protocol. | Posted | Number | Number of Eyes | 1-Week Follow-up | Eyes | Eyes |
|
|
|
|
| Secondary | Number of Eyes With Clinically Significant (Grade 3 or 4 of Overall Classification) Lid Wiper Epitheliopathy | Horizontal lid margin staining and sagittal lid margin staining are graded for each eyelid (upper and lower) separately. The horizontal and sagittal grades are then averaged for each eyelid to obtain the upper lid average grade and lower lid average grade. The final grade is the average of the upper and lower lid average grades. Participants can be classified according to their final grades for each eye. The classification is defined as follows: "None" for final grades of 0, "Mild" for final grades between 0.25 and 1.00, "Moderate" for final grades between 1.25 and 2.00, and "Severe" for final graded between 2.25 and 3.00. Only the interventional arm was reported since the secondary analysis was planned to be conducted among habitual contact lens users only. | All participants who had successfully completed all visits in the interventional arm and did not substantially deviate from the protocol. | Posted | Number | Number of eyes | 1-Week Follow-up | Eyes | Eyes |
|
|
|
|
| Secondary | Meibomian Gland Expressibility (MGE) Grades | Meibomian gland expressiblity was assessed in three regions of the lower eyelid: temporal, central, and nasal. Each region is expressed and the overall grade of the region is evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users. | All participants who had successfully completed all visits in the interventional arm and did not substantially deviate from the protocol. | Posted | Number | Units on a scale | 1-Week Follow-up | Eyes | Eyes |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Test (Senofilcon A) | Subjects that wore the Test article in either the first or second period of the study. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG002 | Control (Spectacle) | Subjects that wore their spectacles in either the first or second period of the study. | 0 | 44 | 0 | 44 | 0 | 44 |
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Point estimates for Test and Control with 95% confidence intervals
| Mixed Model Analysis |
| Mean Proportion |
| 84.17 |
| Standard Error of the Mean |
| 0.871 |
| 2-Sided |
| 95 |
| 48.67 |
| 96.75 |
| Other |
Estimated 95% confidence intervals for the point estimates of Test and Control |
| Nasal: Grade 2 |
|
| Nasal: Grade 3 |
|
| Nasal: Grade 4 |
|
| Temporal: Grade 0 |
|
| Temporal: Grade 1 |
|
| Temporal: Grade 2 |
|
| Temporal: Grade 3 |
|
| Temporal: Grade 4 |
|
| Inferior: Grade 0 |
|
| Inferior: Grade 1 |
|
| Inferior: Grade 2 |
|
| Inferior: Grade 3 |
|
| Inferior: Grade 4 |
|
| Superior: Grade 0 |
|
| Superior: Grade 1 |
|
| Superior: Grade 2 |
|
| Superior: Grade 3 |
|
| Superior: Grade 4 |
|
| Mixed Model Analysis |
Kenward and Rogers Metod was used for degrees of freedom |
| Mean |
| 0.13 |
| Standard Error of the Mean |
| 0.036 |
| 2-Sided |
| 95 |
| -0.19 |
| 0.44 |
| Other |
Estimated 95% confidence intervals for the point estimates of Control. |
Point estimates were calculated for Control. |
| Moderate |
|
| Severe |
|
| Mixed Model Analysis |
| Mean Proportion |
| 27.9 |
| Standard Error of the Mean |
| 18.17 |
| 2-Sided |
| 95 |
| 6.1 |
| 69.8 |
Point estimates were calculated for Control. |
| Other |
Estimated 95% confidence intervals for the point estimates of Control. |
| Central Lower Lid- Grade 2 |
|
| Central Lower Lid- Grade 3 |
|
| Nasal Lower Lid- Grade 0 |
|
| Nasal Lower Lid- Grade 1 |
|
| Nasal Lower Lid- Grade 2 |
|
| Nasal Lower Lid- Grade 3 |
|
| Temporal Lower Lid- Grade 0 |
|
| Temporal Lower Lid- Grade 1 |
|
| Temporal Lower Lid- Grade 2 |
|
| Temporal Lower Lid- Grade 3 |
|