Trial Outcomes & Findings for Mucin Balls and Corneal Inflammation Events (NCT NCT01437319)
NCT ID: NCT01437319
Last Updated: 2018-06-19
Results Overview
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
COMPLETED
PHASE1/PHASE2
289 participants
1-Month Follow-up
2018-06-19
Participant Flow
289 Subjects were enrolled in the study. 7 subjects did not meet the eligibility criteria. 282 subjects entered Phase I. During Phase I, 55 subjects were either lost to follow-up or discontinued. The remaining 227 subjects were randomized to either comfilcon A or balafilcon A and entered Phase II. 146 subjects completed Phase II
During Phase I, subjects are classified as either repeated Mucin Ball former or Non-Repeat Mucin Ball former. The 227 subjects that entered Phase II kept there Mucin ball classification, but were still randomized to either comfilcon A or balafilcon A. All comparisons are made between Mucin Ball classification
Participant milestones
| Measure |
Lotrafilcon A
All subjects received lotrafilcon A in Phase I.
|
Comfilcon A
Subjects that received comfilcon A lens in Phase II.
|
Balfilcon A
Subjects that received balafilcon A lens in Phase II.
|
|---|---|---|---|
|
Phase I
STARTED
|
282
|
0
|
0
|
|
Phase I
COMPLETED
|
227
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
55
|
0
|
0
|
|
Phase II
STARTED
|
0
|
115
|
112
|
|
Phase II
COMPLETED
|
0
|
71
|
75
|
|
Phase II
NOT COMPLETED
|
0
|
44
|
37
|
Reasons for withdrawal
| Measure |
Lotrafilcon A
All subjects received lotrafilcon A in Phase I.
|
Comfilcon A
Subjects that received comfilcon A lens in Phase II.
|
Balfilcon A
Subjects that received balafilcon A lens in Phase II.
|
|---|---|---|---|
|
Phase I
Lost to Follow-up
|
2
|
0
|
0
|
|
Phase I
Protocol Violation
|
1
|
0
|
0
|
|
Phase I
Study related symptoms/complaints
|
27
|
0
|
0
|
|
Phase I
Withdrawal by Subject
|
25
|
0
|
0
|
|
Phase II
Withdrawal by Subject
|
0
|
8
|
16
|
|
Phase II
Lost to Follow-up
|
0
|
7
|
2
|
|
Phase II
Study related symptoms/complaints
|
0
|
28
|
19
|
|
Phase II
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
Mucin Balls and Corneal Inflammation Events
Baseline characteristics by cohort
| Measure |
Overall
n=282 Participants
The analysis population consists of all subjects that were enrolled into the study.
|
|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
282 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-Month Follow-upPopulation: The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective.
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Outcome measures
| Measure |
Repeat Mucin Ball Former
n=161 Participants
Subjects that were classified as being repeat Mucin Ball former.
|
Non-repeat Mucin Ball Former
n=53 Participants
Subjects that were classified as Non-repeat Mucin Ball Former.
|
|---|---|---|
|
Corneal Infiltrate Events - Phase I
|
18.6 percentage of subjects
|
5.7 percentage of subjects
|
PRIMARY outcome
Timeframe: 12-Month Follow-upPopulation: The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification.
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Outcome measures
| Measure |
Repeat Mucin Ball Former
n=153 Participants
Subjects that were classified as being repeat Mucin Ball former.
|
Non-repeat Mucin Ball Former
n=43 Participants
Subjects that were classified as Non-repeat Mucin Ball Former.
|
|---|---|---|
|
Corneal Infiltrate Event- Phase II
balafilcon A, N=66, N=28
|
4.5 percentage of subjects
|
3.6 percentage of subjects
|
|
Corneal Infiltrate Event- Phase II
comfilcon A, N=87, N=15
|
14.9 percentage of subjects
|
33.3 percentage of subjects
|
Adverse Events
Comfilcon A
Balafilcon A
Lotrafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Comfilcon A
n=115 participants at risk
Subjects who received comfilcon A in Phase II of the study.
|
Balafilcon A
n=112 participants at risk
Subjects who received balafilcon A in Phase II of the study
|
Lotrafilcon A
n=282 participants at risk
All Subjects received lotrafilcon A in Phase I of the study.
|
|---|---|---|---|
|
Eye disorders
Asymptomatic corneal scar
|
5.3%
6/114 • Number of events 6 • 1 year
|
2.7%
3/112 • Number of events 3 • 1 year
|
1.1%
3/282 • Number of events 3 • 1 year
|
|
Eye disorders
Cornea Lens Peripheral Ulcer (CLPU)
|
10.4%
12/115 • Number of events 13 • 1 year
|
2.7%
3/112 • Number of events 3 • 1 year
|
3.5%
10/282 • Number of events 10 • 1 year
|
|
Eye disorders
Conjunctivitis
|
10.4%
12/115 • Number of events 25 • 1 year
|
10.7%
12/112 • Number of events 21 • 1 year
|
2.8%
8/282 • Number of events 12 • 1 year
|
|
Eye disorders
SEALs
|
0.00%
0/115 • 1 year
|
5.4%
6/112 • Number of events 6 • 1 year
|
0.71%
2/282 • Number of events 4 • 1 year
|
Additional Information
Tawnya Wilson, OD 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