Trial Outcomes & Findings for Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line (NCT NCT04794270)
NCT ID: NCT04794270
Last Updated: 2022-05-18
Results Overview
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
COMPLETED
NA
72 participants
Fitting, 1-Week Follow-up
2022-05-18
Participant Flow
A total of 72 subjects were enrolled in this study. Of those enrolled, a total of 71 subjects were assigned to one of two wear sequences; while one subject was a screen failure and/or not assigned. Of the total assigned subjects, 68 subjects completed the study while, 3 subjects were discontinued from the study.
Participant milestones
| Measure |
Control/Test
Subjects that wore the Control lens in a bilateral fashion during Period 1 and the Test lens during Period 2.
|
Test/Control
Subjects that wore the Test lens in a bilateral fashion during Period 1 and the Control lens during Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
35
|
36
|
|
Period 1
COMPLETED
|
33
|
36
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
|
Period 2
STARTED
|
33
|
36
|
|
Period 2
COMPLETED
|
32
|
36
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control/Test
Subjects that wore the Control lens in a bilateral fashion during Period 1 and the Test lens during Period 2.
|
Test/Control
Subjects that wore the Test lens in a bilateral fashion during Period 1 and the Control lens during Period 2.
|
|---|---|---|
|
Period 1
Non Compliance
|
1
|
0
|
|
Period 1
Adverse Event
|
1
|
0
|
|
Period 2
Unsatisfactory Lens Fitting due to Test Article
|
1
|
0
|
Baseline Characteristics
Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line
Baseline characteristics by cohort
| Measure |
Dispensed Subject
n=71 Participants
All subjects dispensed a study article.
|
|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 5.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
67 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Fitting, 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Outcome measures
| Measure |
Test
n=58 Participants
All subjects that wore the Test lens during any of the 2 wear periods.
|
Control
n=58 Participants
All subjects that wore the Control lens during any of the 2 wear periods.
|
|---|---|---|
|
CLUE Comfort Score
Fitting
|
65.95 Units on a scale
Standard Deviation 18.645
|
65.13 Units on a scale
Standard Deviation 18.849
|
|
CLUE Comfort Score
1-Week Follow-up
|
67.39 Units on a scale
Standard Deviation 20.024
|
70.80 Units on a scale
Standard Deviation 22.742
|
PRIMARY outcome
Timeframe: Fitting, 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Outcome measures
| Measure |
Test
n=58 Participants
All subjects that wore the Test lens during any of the 2 wear periods.
|
Control
n=58 Participants
All subjects that wore the Control lens during any of the 2 wear periods.
|
|---|---|---|
|
CLUE Vision Score
Fitting
|
70.14 Units on a scale
Standard Deviation 15.979
|
69.64 Units on a scale
Standard Deviation 15.767
|
|
CLUE Vision Score
1-Week Follow-up
|
68.33 Units on a scale
Standard Deviation 18.349
|
72.40 Units on a scale
Standard Deviation 19.381
|
PRIMARY outcome
Timeframe: Fitting, 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Outcome measures
| Measure |
Test
n=58 Participants
All subjects that wore the Test lens during any of the 2 wear periods.
|
Control
n=58 Participants
All subjects that wore the Control lens during any of the 2 wear periods.
|
|---|---|---|
|
CLUE Handling Score
Fitting
|
73.56 Units on a scale
Standard Deviation 19.057
|
72.71 Units on a scale
Standard Deviation 20.760
|
|
CLUE Handling Score
1--Week Follow-up
|
70.61 Units on a scale
Standard Deviation 21.048
|
71.83 Units on a scale
Standard Deviation 19.740
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye. The average visual performance was reported for each lens type.
Outcome measures
| Measure |
Test
n=116 eye
All subjects that wore the Test lens during any of the 2 wear periods.
|
Control
n=116 eye
All subjects that wore the Control lens during any of the 2 wear periods.
|
|---|---|---|
|
Monocular Visual Performance (LogMAR)
|
-0.108 LogMAR
Standard Deviation 0.0703
|
-0.112 LogMAR
Standard Deviation 0.0679
|
PRIMARY outcome
Timeframe: Post-Fitting at 1-minute, at 3-minutePopulation: Subjects that completed all study visits without a major protocol deviation.
Lens rotation was recorded from direction and magnitude in degrees to the nearest degree at one and three minutes following lens insertion during settling period. All lenses in this study have scribe marks at 6 o'clock and 12 o'clock positions and rotation measurements were made relative to a vertical reference line.
Outcome measures
| Measure |
Test
n=116 eye
All subjects that wore the Test lens during any of the 2 wear periods.
|
Control
n=116 eye
All subjects that wore the Control lens during any of the 2 wear periods.
|
|---|---|---|
|
Lens Rotation
At 3-minute
|
-1.1 Degrees
Standard Deviation 4.55
|
-0.8 Degrees
Standard Deviation 4.88
|
|
Lens Rotation
At 1-minute
|
-1.7 Degrees
Standard Deviation 14.65
|
-2.0 Degrees
Standard Deviation 14.94
|
PRIMARY outcome
Timeframe: Fitting, 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Mean settled rotation was calculated from all repeated measures of signed lens orientation upon settling for each subject/eye/lens.
Outcome measures
| Measure |
Test
n=116 eye
All subjects that wore the Test lens during any of the 2 wear periods.
|
Control
n=116 eye
All subjects that wore the Control lens during any of the 2 wear periods.
|
|---|---|---|
|
Settled Rotation
Fitting
|
-0.9 Degrees
Standard Deviation 2.69
|
-1.3 Degrees
Standard Deviation 2.80
|
|
Settled Rotation
1-Week Follow-up
|
-1.8 Degrees
Standard Deviation 3.29
|
-1.6 Degrees
Standard Deviation 3.26
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Straker - Principal Research Optometrist
Johnson & Johnson VIsion Care, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60