Trial Outcomes & Findings for Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses (NCT NCT02595502)
NCT ID: NCT02595502
Last Updated: 2017-07-05
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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.
COMPLETED
NA
286 participants
1 Week
2017-07-05
Participant Flow
A total of 286 subjects were enrolled in this study. Of the enrolled subjects 1 subject did meet the eligibility criteria and 285 subjects were randomized. Of the randomized subjects 9 were discontinued and 276 completed the study.
Participant milestones
| Measure |
Delefilcon A /Senofilcon A/Delefilcon A
Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.
|
Senofilcon A/Delefilcon A/Senofilcon A
Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
|
|---|---|---|
|
Period 1
STARTED
|
143
|
142
|
|
Period 1
COMPLETED
|
142
|
140
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
|
Period 2
STARTED
|
142
|
140
|
|
Period 2
COMPLETED
|
141
|
138
|
|
Period 2
NOT COMPLETED
|
1
|
2
|
|
Period 3
STARTED
|
141
|
138
|
|
Period 3
COMPLETED
|
140
|
136
|
|
Period 3
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Delefilcon A /Senofilcon A/Delefilcon A
Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.
|
Senofilcon A/Delefilcon A/Senofilcon A
Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
|
|---|---|---|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
|
Period 1
Lost to Follow-up
|
0
|
1
|
|
Period 2
Adverse Event
|
1
|
1
|
|
Period 2
Received incorrect lens at Period 1
|
0
|
1
|
|
Period 3
Protocol Violation
|
0
|
1
|
|
Period 3
Lost to Follow-up
|
1
|
0
|
|
Period 3
Received Incorrect Treatment at period 3
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=285 Participants
All subjects that were dispensed at least one study lens throughout the duration of the study.
|
|---|---|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 6.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
36 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
238 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
285 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 WeekPopulation: The analysis population consists of subjects that completed the study 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.
Outcome measures
| Measure |
Delefilcon A
n=410 Number of Observations
Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
|
Senofilcon A
n=405 Number of Observations
Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
|
|---|---|---|
|
Overall Comfort
|
63.07 units on a scale
Standard Deviation 27.752
|
71.87 units on a scale
Standard Deviation 26.494
|
Adverse Events
Delefilcon A
Senofilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall, O.D., M.S., F.A.A.O - Senrior 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