Trial Outcomes & Findings for Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2 (NCT NCT03701516)
NCT ID: NCT03701516
Last Updated: 2022-04-27
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
268 participants
1-week Follow-up
2022-04-27
Participant Flow
A total of 268 subjects were enrolled in this study. Of those enrolled, 263 dispensed at least one study lens while, 5 subjects failed to meet all eligibility criteria. Of those dispensed subjects, 252 subjects completed the study while, 11 subjects were discontinued from the study.
Participant milestones
| Measure |
Test/Control
Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period.
|
Control/Test
Subjects randomized to receive the Control lens during the first period and then receive the Test lens during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
131
|
132
|
|
Period 1
COMPLETED
|
127
|
127
|
|
Period 1
NOT COMPLETED
|
4
|
5
|
|
Period 2
STARTED
|
127
|
127
|
|
Period 2
COMPLETED
|
126
|
126
|
|
Period 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Test/Control
Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period.
|
Control/Test
Subjects randomized to receive the Control lens during the first period and then receive the Test lens during the second period.
|
|---|---|---|
|
Period 1
Lost to Follow-up
|
0
|
1
|
|
Period 1
Adverse Event
|
0
|
2
|
|
Period 1
Unsatisfactory Lens Fitting due to Test Article
|
2
|
0
|
|
Period 1
Non Compliance to Protocol
|
2
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 2
failed to meet all eligibility creiteria
|
1
|
0
|
|
Period 2
Unsatisfactory Lens Fitting due to Test Article
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
Baseline characteristics by cohort
| Measure |
Dispensed Subject
n=263 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
228 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
263 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-week Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
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=237 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control
n=237 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Overall Comfort Scores
|
59.9 unit on a scale
Standard Deviation 24.21
|
60.8 unit on a scale
Standard Deviation 24.69
|
PRIMARY outcome
Timeframe: 1-week Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Overall vision was assessed using the CLUE questionnaire. CLUE is a validated 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 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=237 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control
n=237 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Overall Vision Scores
|
64.2 unit on a scale
Standard Deviation 20.06
|
66.5 unit on a scale
Standard Deviation 19.94
|
SECONDARY outcome
Timeframe: 1-week Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type.
Outcome measures
| Measure |
Test
n=237 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control
n=237 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Average Daily Wear Time
|
14.3 Hours
Standard Deviation 1.92
|
14.4 Hours
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: 1-week Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) 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 at 1-week follow-up. The average visual performance was reported for each lens type.
Outcome measures
| Measure |
Test
n=474 eyes
Subjects that wore the Test lens in either the first or second period of the study.
|
Control
n=474 eyes
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
LLHC LogMAR Visual Performance
|
-0.059 logMAR
Standard Deviation 0.1123
|
-0.060 logMAR
Standard Deviation 0.1176
|
SECONDARY outcome
Timeframe: 1-week Follow-upPopulation: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) 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 at 1-week follow-up. The average visual performance was reported for each lens type.
Outcome measures
| Measure |
Test
n=474 eyes
Subjects that wore the Test lens in either the first or second period of the study.
|
Control
n=474 eyes
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
HLLC LogMAR Visual Performance
|
0.062 logMAR
Standard Deviation 0.1209
|
0.065 logMAR
Standard Deviation 0.1176
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall, OD, MS, FAAO - Director
Johnson & Johnson Vision Care, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60