An interventional study of Spectacles and ACUVUE OASYS®1-Day with HydraLuxe™ Technology in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
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.
Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
Device: Spectacles
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)
Device: Spectacles · Device: ACUVUE OASYS®1-Day with HydraLuxe™ Technology
Subjects' own habitual spectacles
Test 1
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
Time frame: 1-Week Follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1-Week Follow-up
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.
| Milestone | Observational | Interventional: Test (Senofilcon A)/Control (Spectacle) | Interventional: Control (Spectacle)/Test (Senofilcon A) |
|---|---|---|---|
| Started | 21 | 22 | 22 |
| Completed | 21 | 21 | 21 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Test article no longer available | 0 | 1 | 0 |
| Withdrew: No longer meets eligibility criteria | 0 | 0 | 1 |
| Milestone | Observational | Interventional: Test (Senofilcon A)/Control (Spectacle) | Interventional: Control (Spectacle)/Test (Senofilcon A) |
|---|---|---|---|
| Started | 0 | 21 | 21 |
| Completed | 0 | 21 | 21 |
| Not completed | 0 | 0 | 0 |
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
| Seconds | Test (Senofilcon A) | Control (Spectacle) |
|---|---|---|
| Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT) | 8.28 ± 4.482 | 11.10 ± 5.761 |
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.
| Units on a scale | Test (Senofilcon A) | Control (Spectacle) |
|---|---|---|
| Total Scores of Meibomian Gland Expressibility (MGE) | 8.5 ± 1.24 | 8.5 ± 1.28 |
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.
| Number of Eyes | Test (Senofilcon A) | Control (Spectacle) |
|---|---|---|
| Nasal: Grade 0 | 41 | 59 |
| Nasal: Grade 1 | 34 | 23 |
| Nasal: Grade 2 | 7 | 0 |
| Nasal: Grade 3 | 0 | 0 |
| Nasal: Grade 4 | 0 | 0 |
| Temporal: Grade 0 | 55 | 79 |
| Temporal: Grade 1 | 25 | 3 |
| Temporal: Grade 2 | 2 | 0 |
| Temporal: Grade 3 | 0 | 0 |
| Temporal: Grade 4 | 0 | 0 |
| Inferior: Grade 0 | 40 | 75 |
| Inferior: Grade 1 | 34 | 6 |
| Inferior: Grade 2 | 7 | 1 |
| Inferior: Grade 3 | 1 | 0 |
| Inferior: Grade 4 | 0 | 0 |
| Superior: Grade 0 | 71 | 82 |
| Superior: Grade 1 | 9 | 0 |
| Superior: Grade 2 | 2 | 0 |
| Superior: Grade 3 | 0 | 0 |
| Superior: Grade 4 | 0 | 0 |
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.
| Number of eyes | Test (Senofilcon A) | Control (Spectacle) |
|---|---|---|
| None | 36 | 31 |
| Mild | 15 | 19 |
| Moderate | 29 | 30 |
| Severe | 2 | 2 |
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.
| Units on a scale | Test (Senofilcon A) | Control (Spectacle) |
|---|---|---|
| Central Lower Lid- Grade 0 | 0 | 0 |
| Central Lower Lid- Grade 1 | 0 | 0 |
| Central Lower Lid- Grade 2 | 10 | 6 |
| Central Lower Lid- Grade 3 | 72 | 76 |
| Nasal Lower Lid- Grade 0 | 0 | 1 |
| Nasal Lower Lid- Grade 1 | 2 | 0 |
| Nasal Lower Lid- Grade 2 | 9 | 7 |
| Nasal Lower Lid- Grade 3 | 71 | 74 |
| Temporal Lower Lid- Grade 0 | 2 | 6 |
| Temporal Lower Lid- Grade 1 | 4 | 2 |
| Temporal Lower Lid- Grade 2 | 5 | 5 |
| Temporal Lower Lid- Grade 3 | 71 | 69 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observational | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Test (Senofilcon A) | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Control (Spectacle) | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
All subjects who were assigned either to the interventional arm or the observational arm based on their habitual vision corrections.
| Age, Continuous(Years) | Observational Arm | Interventional Arms | Total |
|---|---|---|---|
| Mean | 29.1 ± 6.40 | 28.9 ± 7.00 | 29.0 ± 6.76 |
| Sex: Female, Male(Participants) | Observational Arm | Interventional Arms | Total |
|---|---|---|---|
| Female | 16 | 26 | 42 |
| Male | 5 | 18 | 23 |
| Race (NIH/OMB)(Participants) | Observational Arm | Interventional Arms | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 4 | 3 | 7 |
| White | 11 | 32 | 43 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Region of Enrollment(Participants) | Observational Arm | Interventional Arms | Total |
|---|---|---|---|
| United States | 21 | 44 | 65 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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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Johnson & Johnson Vision Care, Inc.