Trial Outcomes & Findings for Vistakon Investigational Contact Lenses Worn for Daily Wear (NCT NCT00717249)
NCT ID: NCT00717249
Last Updated: 2016-05-26
Results Overview
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
COMPLETED
NA
529 participants
6 months
2016-05-26
Participant Flow
A total of 529 subjects were enrolled in this study. Of those enrolled subjects, 33 did not meet the eligibility criteria and 496 were randomized to either the test or control lens using a 2:1 allocation. Of those randomized subjects 491 were successfully dispensed. Of the dispensed subjects 454 subjects completed the study.
Participant milestones
| Measure |
Galyfilcon A w/ Silver
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
326
|
165
|
|
Overall Study
COMPLETED
|
304
|
150
|
|
Overall Study
NOT COMPLETED
|
22
|
15
|
Reasons for withdrawal
| Measure |
Galyfilcon A w/ Silver
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
|---|---|---|
|
Overall Study
Lens Discomfort
|
4
|
1
|
|
Overall Study
Unsatisfactory visual Response
|
0
|
2
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Pregnancy
|
6
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Subject became Ineligible
|
1
|
1
|
|
Overall Study
Unsatisfactory Physiological Response
|
0
|
1
|
|
Overall Study
Gastric Surgery
|
0
|
1
|
|
Overall Study
Diagnosed with Diabetes
|
1
|
0
|
|
Overall Study
Diagnosed with Multiple Scletosis
|
1
|
0
|
|
Overall Study
Subject relocated
|
1
|
0
|
|
Overall Study
Headaches
|
1
|
0
|
Baseline Characteristics
Vistakon Investigational Contact Lenses Worn for Daily Wear
Baseline characteristics by cohort
| Measure |
Galyfilcon A w/ Silver
n=326 Participants
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
n=165 Participants
Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
|
Total
n=491 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.9 years
n=5 Participants
|
29.8 years
n=7 Participants
|
30.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
304 participants
n=5 Participants
|
147 participants
n=7 Participants
|
451 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Indian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
326 participants
n=5 Participants
|
165 participants
n=7 Participants
|
491 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
Outcome measures
| Measure |
Galyfilcon A w/ Silver
n=608 Subject Eyes
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
n=300 Subject Eyes
Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
|
|---|---|---|
|
Slit Lamp Findings
|
7 Number of Subject Eyes
|
2 Number of Subject Eyes
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.
Outcome measures
| Measure |
Galyfilcon A w/ Silver
n=2548 Number of Observations
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
n=1260 Number of Observations
Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
|
|---|---|---|
|
Subject Reported Symptoms
Dryness
|
9.9 Percentage of Observations
|
6.3 Percentage of Observations
|
|
Subject Reported Symptoms
Other
|
4.9 Percentage of Observations
|
4.0 Percentage of Observations
|
|
Subject Reported Symptoms
Cloudy/ Blurry / Hazy
|
2.8 Percentage of Observations
|
2.5 Percentage of Observations
|
|
Subject Reported Symptoms
Irritation / Discomfort
|
2.8 Percentage of Observations
|
2.3 Percentage of Observations
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.
Outcome measures
| Measure |
Galyfilcon A w/ Silver
n=304 Participants
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
n=150 Participants
Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
|
|---|---|---|
|
Visual Acuity
|
0.004 LogMAR
Standard Deviation 0.0891
|
-0.009 LogMAR
Standard Deviation 0.0866
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.
Outcome measures
| Measure |
Galyfilcon A w/ Silver
n=304 Participants
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
n=150 Participants
Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
|
|---|---|---|
|
Average Contact Lens Wear Time
|
14.0 time in hours
Interval 13.92 to 14.03
|
14.0 time in hours
Interval 13.95 to 14.04
|
Adverse Events
Galyfilcon A w/ Silver
Galyfilcon A
Serious adverse events
| Measure |
Galyfilcon A w/ Silver
n=326 participants at risk
Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
|
Galyfilcon A
n=165 participants at risk
Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
|
|---|---|---|
|
Eye disorders
Iritis
|
0.00%
0/326 • Throughout the duration of the study. Approximately 6 months.
|
0.61%
1/165 • Number of events 1 • Throughout the duration of the study. Approximately 6 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall, O.D., M.S. 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