Trial Outcomes & Findings for Evaluation of Etafilcon A Daily Disposable Lenses (NCT NCT02061592)
NCT ID: NCT02061592
Last Updated: 2018-06-19
Results Overview
Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
COMPLETED
NA
136 participants
1-week follow-up
2018-06-19
Participant Flow
128 of the 136 subjects were randomized. 8 subjects did not meet the eligibility criteria. 3 subjects were discontinued from the study. 12 subjects were excluded from analysis due to major protocol deviations. 113 subjects completed all study visits without a major protocol deviation.
Participant milestones
| Measure |
Control/Test
Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
|
Test/Control
Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
|
|---|---|---|
|
Period 1
STARTED
|
66
|
62
|
|
Period 1
COMPLETED
|
64
|
62
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
|
Period 2
STARTED
|
64
|
62
|
|
Period 2
COMPLETED
|
64
|
61
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control/Test
Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
|
Test/Control
Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
|
Period 1
Protocol Violation
|
1
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Evaluation of Etafilcon A Daily Disposable Lenses
Baseline characteristics by cohort
| Measure |
Control/Test
n=66 Participants
Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
|
Test/Control
n=62 Participants
Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 9.02 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 7.48 • n=7 Participants
|
31.0 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
62 participants
n=7 Participants
|
128 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-week follow-upPopulation: Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.
Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Outcome measures
| Measure |
Control
n=113 Participants
Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
|
Test
n=113 Participants
Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
|
|---|---|---|
|
Overall Comfort
|
60.1 units on a scale
Standard Deviation 18.47
|
43.6 units on a scale
Standard Deviation 20.19
|
PRIMARY outcome
Timeframe: 1- week Follow-upPopulation: Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.
Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Outcome measures
| Measure |
Control
n=113 Participants
Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
|
Test
n=113 Participants
Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
|
|---|---|---|
|
Overall Vision
|
64.9 units on a scale
Standard Deviation 18.23
|
58.0 units on a scale
Standard Deviation 19.51
|
PRIMARY outcome
Timeframe: 1-week follow-upPopulation: Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Outcome measures
| Measure |
Control
n=200 Eyes
Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
|
Test
n=200 Eyes
Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
|
|---|---|---|
|
Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim
|
0.030 LogMar
Standard Deviation 0.088
|
0.020 LogMar
Standard Deviation 0.085
|
PRIMARY outcome
Timeframe: 1- week Follow-upPopulation: Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Outcome measures
| Measure |
Control
n=226 Eyes
Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
|
Test
n=226 Eyes
Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
|
|---|---|---|
|
Monocular logMar Visual Acuity - Standard Low Contrast Bright
|
0.060 LogMar
Standard Deviation 0.083
|
0.050 LogMar
Standard Deviation 0.079
|
Adverse Events
Control
Test
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall, OD, MS, FAAO - Senior Principal Research Optometrist
Johnson & Johnson Vision Care, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submission for publication or presentation the Institution will provide sponsor with at least sixty (60) days for review of a manuscript. If needed, the Institution and Principal Investigator will withhold publication for up to an additional sixty days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER