Trial Outcomes & Findings for A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week (NCT NCT02543528)
NCT ID: NCT02543528
Last Updated: 2019-10-01
Results Overview
The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
171 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2019-10-01
Participant Flow
This study utilized an adaptation period of 14 days prior to dispensing the extended wear contact lenses. A total of 171 subjects were enrolled into the adaption period. Of those enrolled into this period 168 were dispensed a study lens and 3 did not meet the eligibility criteria. Of the 168 dispensed subjects 142 completed the adaptation period.
A total of 26 subjects were discontinued from the adaptation period. A total of 142 subjects were enrolled into the extended wear period. Of the enrolled subjects, all 142 were dispensed a study lens. Of the dispensed subjects in the extended wear period 58 completed the study and 84 subjects discontinued from the study.
Participant milestones
| Measure |
Investigational Lens 1
Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
|
Investigational Lens 2
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
|
Investigational Lens 3
Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
|
Etafilcon A (Resuable)
Subjects that were randomized to receive the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
|
Etafilcon A (1-Day)
All subjects wore the etafilcon A 1-Day contact lens during the 2-week adaptation period.
|
|---|---|---|---|---|---|
|
Adaptation Period
STARTED
|
0
|
0
|
0
|
0
|
168
|
|
Adaptation Period
COMPLETED
|
0
|
0
|
0
|
0
|
142
|
|
Adaptation Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
26
|
|
Extended Wear Period
STARTED
|
36
|
35
|
36
|
35
|
0
|
|
Extended Wear Period
COMPLETED
|
8
|
14
|
13
|
23
|
0
|
|
Extended Wear Period
NOT COMPLETED
|
28
|
21
|
23
|
12
|
0
|
Reasons for withdrawal
| Measure |
Investigational Lens 1
Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
|
Investigational Lens 2
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
|
Investigational Lens 3
Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
|
Etafilcon A (Resuable)
Subjects that were randomized to receive the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
|
Etafilcon A (1-Day)
All subjects wore the etafilcon A 1-Day contact lens during the 2-week adaptation period.
|
|---|---|---|---|---|---|
|
Adaptation Period
Unsatisfactory Lens Fitting
|
0
|
0
|
0
|
0
|
2
|
|
Adaptation Period
Lens Handling Difficultes
|
0
|
0
|
0
|
0
|
8
|
|
Adaptation Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
14
|
|
Adaptation Period
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
|
Extended Wear Period
Adverse Event
|
17
|
11
|
16
|
3
|
0
|
|
Extended Wear Period
Missed too many scheduled visits
|
0
|
0
|
1
|
3
|
0
|
|
Extended Wear Period
Unsatisfactory Lens Fitting
|
1
|
0
|
0
|
0
|
0
|
|
Extended Wear Period
Lost to Follow-up
|
0
|
1
|
2
|
1
|
0
|
|
Extended Wear Period
Withdrawal by Subject
|
10
|
9
|
4
|
5
|
0
|
Baseline Characteristics
All subjects enrolled into the adaptation or extended wear period of the study.
Baseline characteristics by cohort
| Measure |
All Dispensed Subjects
n=168 Participants
All subjects dispensed at least 1 study lens.
|
|---|---|
|
Age, Continuous
|
20.2 Years
STANDARD_DEVIATION 2.80 • n=93 Participants • All subjects enrolled into the adaptation or extended wear period of the study.
|
|
Sex/Gender, Customized
Female
|
108 Participants
n=93 Participants • All subjects enrolled into the adaptation or extended wear period of the study.
|
|
Sex/Gender, Customized
Male
|
60 Participants
n=93 Participants • All subjects enrolled into the adaptation or extended wear period of the study.
|
|
Race/Ethnicity, Customized
Asian Indian
|
168 Participants
n=93 Participants • All subjects that were enrolled into the adaptation or extended wear period of the study.
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: The analysis population consists of all subjects that were enrolled into the extended wear period.
The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.
Outcome measures
| Measure |
Investigational Lens 1
n=72 Eyes
Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
|
Investigational Lens 3
n=72 Eyes
Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
|
Investigational Lens 2
n=70 Eyes
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
|
Etafilcon A (Resuable)
n=70 Eyes
Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
|
|---|---|---|---|---|
|
Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)
|
14 Number of Events
|
13 Number of Events
|
12 Number of Events
|
1 Number of Events
|
SECONDARY outcome
Timeframe: Time Frame Up to 6 monthsPopulation: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.
Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes 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 indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.
Outcome measures
| Measure |
Investigational Lens 1
n=8 Participants
Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
|
Investigational Lens 3
n=13 Participants
Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
|
Investigational Lens 2
n=14 Participants
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
|
Etafilcon A (Resuable)
n=23 Participants
Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
|
|---|---|---|---|---|
|
Overall Comfort Score
1-Day Follow-up
|
59.39 Units on a Scale
Standard Deviation 14.263
|
60.22 Units on a Scale
Standard Deviation 9.005
|
58.85 Units on a Scale
Standard Deviation 13.102
|
62.51 Units on a Scale
Standard Deviation 13.431
|
|
Overall Comfort Score
5-Day Follow-up
|
58.38 Units on a Scale
Standard Deviation 9.293
|
60.12 Units on a Scale
Standard Deviation 8.447
|
58.29 Units on a Scale
Standard Deviation 9.735
|
64.59 Units on a Scale
Standard Deviation 13.301
|
|
Overall Comfort Score
12-Day Follow-up
|
60.94 Units on a Scale
Standard Deviation 9.620
|
65.74 Units on a Scale
Standard Deviation 12.091
|
58.95 Units on a Scale
Standard Deviation 13.457
|
64.87 Units on a Scale
Standard Deviation 13.831
|
|
Overall Comfort Score
26-Day Follow-up
|
60.20 Units on a Scale
Standard Deviation 12.851
|
65.41 Units on a Scale
Standard Deviation 16.467
|
57.35 Units on a Scale
Standard Deviation 15.280
|
65.57 Units on a Scale
Standard Deviation 14.513
|
|
Overall Comfort Score
88-Day Follow-up
|
59.54 Units on a Scale
Standard Deviation 7.474
|
55.59 Units on a Scale
Standard Deviation 15.247
|
57.71 Units on a Scale
Standard Deviation 12.150
|
65.00 Units on a Scale
Standard Deviation 15.657
|
|
Overall Comfort Score
180-Day Follow-up
|
57.81 Units on a Scale
Standard Deviation 9.133
|
62.69 Units on a Scale
Standard Deviation 14.600
|
54.91 Units on a Scale
Standard Deviation 7.578
|
64.49 Units on a Scale
Standard Deviation 16.120
|
SECONDARY outcome
Timeframe: Time Frame Up to 6 monthsPopulation: The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.
Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes 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 indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.
Outcome measures
| Measure |
Investigational Lens 1
n=8 Participants
Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
|
Investigational Lens 3
n=13 Participants
Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
|
Investigational Lens 2
n=14 Participants
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
|
Etafilcon A (Resuable)
n=23 Participants
Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
|
|---|---|---|---|---|
|
Overall Vision Score
1-Day Follow-up
|
55.27 Units on a Scale
Standard Deviation 15.819
|
56.78 Units on a Scale
Standard Deviation 14.299
|
52.87 Units on a Scale
Standard Deviation 12.857
|
60.28 Units on a Scale
Standard Deviation 14.723
|
|
Overall Vision Score
5-Day Follow-up
|
53.02 Units on a Scale
Standard Deviation 9.117
|
54.66 Units on a Scale
Standard Deviation 14.398
|
52.11 Units on a Scale
Standard Deviation 13.284
|
59.55 Units on a Scale
Standard Deviation 15.169
|
|
Overall Vision Score
12-Day Follow-up
|
52.17 Units on a Scale
Standard Deviation 13.614
|
59.63 Units on a Scale
Standard Deviation 17.147
|
50.73 Units on a Scale
Standard Deviation 11.715
|
59.59 Units on a Scale
Standard Deviation 14.892
|
|
Overall Vision Score
26-Day Follow-up
|
52.85 Units on a Scale
Standard Deviation 5.218
|
57.84 Units on a Scale
Standard Deviation 13.257
|
50.38 Units on a Scale
Standard Deviation 17.434
|
59.76 Units on a Scale
Standard Deviation 14.244
|
|
Overall Vision Score
88-Day Follow-up
|
50.23 Units on a Scale
Standard Deviation 17.080
|
54.22 Units on a Scale
Standard Deviation 14.718
|
50.67 Units on a Scale
Standard Deviation 10.777
|
63.83 Units on a Scale
Standard Deviation 17.096
|
|
Overall Vision Score
180-Day Follow-up
|
53.49 Units on a Scale
Standard Deviation 9.883
|
54.07 Units on a Scale
Standard Deviation 10.654
|
50.92 Units on a Scale
Standard Deviation 9.699
|
61.68 Units on a Scale
Standard Deviation 16.426
|
Adverse Events
Etafilcon A (1-Day)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Investigational Lens 1
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Investigational Lens 2
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Investigational Lens 3
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Etafilcon A (Resuable)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etafilcon A (1-Day)
n=168 participants at risk
All subject wore the etafilcon A (1-Day) contact lens throughout the entire duration of the adaptation period (14-Days).
|
Investigational Lens 1
n=36 participants at risk
Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
|
Investigational Lens 2
n=35 participants at risk
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
|
Investigational Lens 3
n=36 participants at risk
Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
|
Etafilcon A (Resuable)
n=35 participants at risk
Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
|
|---|---|---|---|---|---|
|
Eye disorders
Iritis
|
0.00%
0/168 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
0.00%
0/36 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
0.00%
0/35 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
8.3%
3/36 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.9%
1/35 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
Other adverse events
| Measure |
Etafilcon A (1-Day)
n=168 participants at risk
All subject wore the etafilcon A (1-Day) contact lens throughout the entire duration of the adaptation period (14-Days).
|
Investigational Lens 1
n=36 participants at risk
Subjects that were randomized to receive the investigational contact lens 1 throughout the entire duration of the extended wear period.
|
Investigational Lens 2
n=35 participants at risk
Subjects that were randomized to receive the investigational contact lens 2 throughout the entire duration of the extended wear period.
|
Investigational Lens 3
n=36 participants at risk
Subjects that were randomized to receive the investigational contact lens 3 throughout the entire duration of the extended wear period.
|
Etafilcon A (Resuable)
n=35 participants at risk
Subjects that were randomized to received the etafilcon A (Reusable) lens throughout the entire duration of the extended wear period.
|
|---|---|---|---|---|---|
|
Immune system disorders
Fever
|
3.0%
5/168 • Number of events 5 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.6%
2/36 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
11.4%
4/35 • Number of events 4 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.8%
1/36 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
17.1%
6/35 • Number of events 6 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
CLPC (Contact Lens Papillary Conjunctivitis)
|
0.00%
0/168 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.6%
2/36 • Number of events 4 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.7%
2/35 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.6%
2/36 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
0.00%
0/35 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
Meibomianitis
|
0.60%
1/168 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.6%
2/36 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
0.00%
0/35 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.8%
1/36 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
0.00%
0/35 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
NSIE (Non-significant Infiltrative Event)
|
0.60%
1/168 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.6%
2/36 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
14.3%
5/35 • Number of events 5 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
11.1%
4/36 • Number of events 4 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.7%
2/35 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
Corneal Foreign Body
|
1.8%
3/168 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.8%
1/36 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.9%
1/35 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
11.1%
4/36 • Number of events 4 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.9%
1/35 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
Slit Lamp Findings Grade 2 or less requiring treatment
|
0.60%
1/168 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.8%
1/36 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
0.00%
0/35 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.6%
2/36 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
5.7%
2/35 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
SPK (Superficial Punctate Keratitis)
|
0.00%
0/168 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.8%
1/36 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
8.6%
3/35 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
11.1%
4/36 • Number of events 4 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.9%
1/35 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
Symptoms Problems or Complaints Requiring Treatment
|
0.60%
1/168 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
16.7%
6/36 • Number of events 6 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
8.6%
3/35 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
8.3%
3/36 • Number of events 3 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
11.4%
4/35 • Number of events 7 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
CLPU (Contact Lens induced Peripheral Ulcer)
|
0.00%
0/168 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
33.3%
12/36 • Number of events 12 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
28.6%
10/35 • Number of events 10 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
27.8%
10/36 • Number of events 12 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
0.00%
0/35 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
Asymptomatic Corneal Scar
|
0.00%
0/168 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
16.7%
6/36 • Number of events 8 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
20.0%
7/35 • Number of events 9 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
16.7%
6/36 • Number of events 8 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
14.3%
5/35 • Number of events 5 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
|
Eye disorders
SIE (Significant Infiltrative Event)
|
0.00%
0/168 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.8%
1/36 • Number of events 2 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
11.4%
4/35 • Number of events 5 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
8.3%
3/36 • Number of events 4 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
2.9%
1/35 • Number of events 1 • Throughout the entire duration of the study. Approximately 6 months per subject.
|
Additional Information
Elizabeth Dow -PRINCIPAL RESEARCH OPTOMETRIST
Johnson & Johnson Vision
Phone: 904-443-1061
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60