Trial Outcomes & Findings for Quantitative Study of New Limbal Ring Prototypes (NCT NCT02173535)
NCT ID: NCT02173535
Last Updated: 2018-06-19
Results Overview
Subjects' responses to the question "Make my eye look bigger" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
15-20 Minutes Post Lens Insertion
Results posted on
2018-06-19
Participant Flow
A total of 257 subjects were enrolled into this study. Of the enrolled subjects, 240 subjects were dispensed at least 1 study lenses, while 17 subjects failed to meet the eligibility criteria. No subjects were discontinued during the course of this study.
Participant milestones
| Measure |
AP-CS-LA-JG-VC
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
AP-JG-CS-VC-LA
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
AP-LA-VC-CS-JG
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
AP-VC-JG-LA-CS
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-AP-VC-JG-LA
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-JG-AP-LA-VC
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-VC-LA-AP-JG
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-LA-JG-VC-AP
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-AP-LA-VC-CS
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-CS-VC-LA-AP
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-LA-CS-AP-VC
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-VC-AP-CS-LA
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-AP-JG-CS-VC
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-CS-AP-VC-JG
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-JG-VC-AP-CS
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-VC-CS-JG-AP
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-AP-CS-LA-JG
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-CS-JG-AP-LA
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-JG-LA-CS-AP
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-LA-AP-JG-CS
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
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Period 1
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Period 3
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Period 5
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Period 5
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Period 5
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quantitative Study of New Limbal Ring Prototypes
Baseline characteristics by cohort
| Measure |
AP-CS-LA-JG-VC
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
AP-JG-CS-VC-LA
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
AP-LA-VC-CS-JG
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
AP-VC-JG-LA-CS
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-AP-VC-JG-LA
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-JG-AP-LA-VC
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-VC-LA-AP-JG
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
CS-LA-JG-VC-AP
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-AP-LA-VC-CS
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-CS-VC-LA-AP
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-LA-CS-AP-VC
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
JG-VC-AP-CS-LA
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-AP-JG-CS-VC
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-CS-AP-VC-JG
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-JG-VC-AP-CS
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
LA-VC-CS-JG-AP
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-AP-CS-LA-JG
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-CS-JG-AP-LA
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-JG-LA-CS-AP
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
VC-LA-AP-JG-CS
n=12 Participants
All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.1 Years
STANDARD_DEVIATION 5.84 • n=5 Participants
|
26.9 Years
STANDARD_DEVIATION 5.78 • n=7 Participants
|
27.9 Years
STANDARD_DEVIATION 4.96 • n=5 Participants
|
28.0 Years
STANDARD_DEVIATION 5.80 • n=4 Participants
|
30.3 Years
STANDARD_DEVIATION 6.06 • n=21 Participants
|
27.5 Years
STANDARD_DEVIATION 4.93 • n=8 Participants
|
28.2 Years
STANDARD_DEVIATION 6.99 • n=8 Participants
|
26.8 Years
STANDARD_DEVIATION 6.58 • n=24 Participants
|
28.9 Years
STANDARD_DEVIATION 5.62 • n=42 Participants
|
26.6 Years
STANDARD_DEVIATION 4.27 • n=42 Participants
|
27.5 Years
STANDARD_DEVIATION 5.04 • n=42 Participants
|
27.3 Years
STANDARD_DEVIATION 5.88 • n=42 Participants
|
29.1 Years
STANDARD_DEVIATION 5.37 • n=36 Participants
|
26.8 Years
STANDARD_DEVIATION 4.37 • n=36 Participants
|
27.85 Years
STANDARD_DEVIATION 5.50 • n=24 Participants
|
26.3 Years
STANDARD_DEVIATION 5.80 • n=135 Participants
|
27.8 Years
STANDARD_DEVIATION 6.29 • n=136 Participants
|
29.9 Years
STANDARD_DEVIATION 6.53 • n=44 Participants
|
27.6 Years
STANDARD_DEVIATION 2.97 • n=667 Participants
|
30.1 Years
STANDARD_DEVIATION 5.11 • n=12 Participants
|
28.0 Years
STANDARD_DEVIATION 5.46 • n=12 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
12 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
12 Participants
n=12 Participants
|
240 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
12 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
12 Participants
n=12 Participants
|
240 Participants
n=12 Participants
|
|
Region of Enrollment
China
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
12 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
12 Participants
n=12 Participants
|
240 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 15-20 Minutes Post Lens InsertionPopulation: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints
Subjects' responses to the question "Make my eye look bigger" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens.
Outcome measures
| Measure |
AP- Etafilcon A
n=236 Participants
Subjects that wore the AP investigational lens during any of the 5 period of the study.
|
CS- Etafilcon A
n=236 Participants
Subjects that wore the CS investigational lens during any of the 5 period of the study.
|
JG-etafilcon A
n=236 Participants
Subjects that wore the JG investigational lens during any of the 5 period of the study.
|
LA-etafilcon A
n=236 Participants
Subjects that wore the LA investigational lens during any of the 5 period of the study.
|
VC- Etafilcon A
n=236 Participants
Subjects that wore the VC investigational lens during any of the 5 period of the study.
|
|---|---|---|---|---|---|
|
Number of Subject in Agreement (Bigger Eyes)
|
187 Participants
|
213 Participants
|
206 Participants
|
209 Participants
|
208 Participants
|
PRIMARY outcome
Timeframe: 15-20 Minutes Post Lens InsertionPopulation: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints
Subjects' responses to the question "Define my eye" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens.
Outcome measures
| Measure |
AP- Etafilcon A
n=236 Participants
Subjects that wore the AP investigational lens during any of the 5 period of the study.
|
CS- Etafilcon A
n=236 Participants
Subjects that wore the CS investigational lens during any of the 5 period of the study.
|
JG-etafilcon A
n=236 Participants
Subjects that wore the JG investigational lens during any of the 5 period of the study.
|
LA-etafilcon A
n=236 Participants
Subjects that wore the LA investigational lens during any of the 5 period of the study.
|
VC- Etafilcon A
n=236 Participants
Subjects that wore the VC investigational lens during any of the 5 period of the study.
|
|---|---|---|---|---|---|
|
Number of Subject in Agreement (Defines Eyes)
|
175 Participants
|
189 Participants
|
180 Participants
|
188 Participants
|
192 Participants
|
PRIMARY outcome
Timeframe: 15-20 Minutes Post Lens InsertionPopulation: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints
Subjects' responses to the question "Enhance my overall appearance" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens.
Outcome measures
| Measure |
AP- Etafilcon A
n=236 Participants
Subjects that wore the AP investigational lens during any of the 5 period of the study.
|
CS- Etafilcon A
n=236 Participants
Subjects that wore the CS investigational lens during any of the 5 period of the study.
|
JG-etafilcon A
n=236 Participants
Subjects that wore the JG investigational lens during any of the 5 period of the study.
|
LA-etafilcon A
n=236 Participants
Subjects that wore the LA investigational lens during any of the 5 period of the study.
|
VC- Etafilcon A
n=236 Participants
Subjects that wore the VC investigational lens during any of the 5 period of the study.
|
|---|---|---|---|---|---|
|
Number of Subject in Agreement (Enhance Eyes)
|
167 Participants
|
180 Participants
|
177 Participants
|
170 Participants
|
185 Participants
|
Adverse Events
AP-CS-LA-JG-VC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AP-JG-CS-VC-LA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AP-LA-VC-CS-JG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AP-VC-JG-LA-CS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CS-AP-VC-JG-LA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CS-JG-AP-LA-VC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CS-VC-LA-AP-JG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CS-LA-JG-VC-AP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
JG-AP-LA-VC-CS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
JG-CS-VC-LA-AP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
JG-LA-CS-AP-VC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
JG-VC-AP-CS-LA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LA-AP-JG-CS-VC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LA-CS-AP-VC-JG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LA-JG-VC-AP-CS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LA-VC-CS-JG-AP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VC-AP-CS-LA-JG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VC-CS-JG-AP-LA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VC-JG-LA-CS-AP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VC-LA-AP-JG-CS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Charis Lau, Pharm.D., O.D., FAAO
Johnson & Johnson Vision Care Inc.
Phone: (904) 443-1293
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60