Trial Outcomes & Findings for Evaluation of Prototype Lenses With Experimental UV/HEV Blocker (NCT NCT04885296)
NCT ID: NCT04885296
Last Updated: 2022-09-01
Results Overview
Overall quality of vision scores were 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. The average CLUE vision score for each lens type was reported.
COMPLETED
NA
228 participants
2-Week Follow-up
2022-09-01
Participant Flow
A total of 228 subjects were enrolled in this study. Of those enrolled, 227 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 219 subjects completed the study while 8 subjects were discontinued.
Participant milestones
| Measure |
Control (Senofilcon A C3) /Test (Senofilcon A C3)
Subjects randomized to this sequence received the Control lens during the first period and Test lens during the second period.
|
Test (Senofilcon A C3) /Control (Senofilcon A C3)
Subjects randomized to this sequence received the Test lens during the first period and Control lens during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
117
|
110
|
|
Period 1
COMPLETED
|
112
|
108
|
|
Period 1
NOT COMPLETED
|
5
|
2
|
|
Period 2
STARTED
|
112
|
108
|
|
Period 2
COMPLETED
|
112
|
107
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control (Senofilcon A C3) /Test (Senofilcon A C3)
Subjects randomized to this sequence received the Control lens during the first period and Test lens during the second period.
|
Test (Senofilcon A C3) /Control (Senofilcon A C3)
Subjects randomized to this sequence received the Test lens during the first period and Control lens during the second period.
|
|---|---|---|
|
Period 1
Covid-19 Related
|
1
|
0
|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
1
|
1
|
|
Period 1
Test Article No Longer Available
|
1
|
0
|
|
Period 1
Dispensed Study lens in Error
|
1
|
0
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 2
Subject No Longer Meets Eligibility Criteria
|
0
|
1
|
Baseline Characteristics
Evaluation of Prototype Lenses With Experimental UV/HEV Blocker
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=227 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 5.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
174 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
227 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Overall quality of vision scores were 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. The average CLUE vision score for each lens type was reported.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=216 Participants
Subjects that wore the Test lens in either of the two study periods.
|
Control (Senofilcon A C3)
n=216 Participants
Subjects that wore the Control lens in either of the two study periods.
|
|---|---|---|
|
Overall Quality of Vision Score
|
69.3 Unit on a scale
Standard Deviation 20.84
|
69.0 Unit on a scale
Standard Deviation 22.12
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Overall comfort scores were 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. The average CLUE comfort score for each lens type was reported.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=216 Participants
Subjects that wore the Test lens in either of the two study periods.
|
Control (Senofilcon A C3)
n=216 Participants
Subjects that wore the Control lens in either of the two study periods.
|
|---|---|---|
|
Overall Comfort Scores
|
68.1 Unit on a scale
Standard Deviation 24.58
|
69.0 Unit on a scale
Standard Deviation 24.08
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Overall handling scores were 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. The average CLUE handling score for each lens type was reported.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=216 Participants
Subjects that wore the Test lens in either of the two study periods.
|
Control (Senofilcon A C3)
n=216 Participants
Subjects that wore the Control lens in either of the two study periods.
|
|---|---|---|
|
Overall Handling Scores
|
66.9 Unit on a scale
Standard Deviation 23.94
|
68.6 Unit on a scale
Standard Deviation 22.72
|
Adverse Events
Control (Senofilcon A C3)
Test (Senofilcon A C3)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John R. Buch, O.D., M.S., F.A.A.O.
Johnson & Johnson Vision Care, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60