Trial Outcomes & Findings for Vistakon Investigational Multi-purpose Contact Lens Care Solution. (NCT NCT01055457)
NCT ID: NCT01055457
Last Updated: 2018-06-19
Results Overview
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
315 participants
Primary outcome timeframe
Up to 3 months Post Lens Wear
Results posted on
2018-06-19
Participant Flow
A total of 315 subjects were enrolled in this study. Of the enrolled subjects 20 did not meet the eligibility criteria and 295 subjects were randomized to treatment.Of the randomized subjects 16 were discontinued from the study, while 279 completed the study.
Allocation of subjects to the 5 contact lenses was fairly balanced ranging from 57 to 61 subjects per lens, while the allocation of subjects to solution was 2:1 for the test and control solution respectively.
Participant milestones
| Measure |
Solution1 (Etafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Comfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Balafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Lotrafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Galyfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution2 (Etafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Comfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Balafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Lotrafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Galyfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
38
|
40
|
41
|
18
|
19
|
19
|
20
|
20
|
|
Overall Study
COMPLETED
|
39
|
39
|
36
|
37
|
38
|
15
|
18
|
18
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
3
|
3
|
3
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Solution1 (Etafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Comfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Balafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Lotrafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Galyfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution2 (Etafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Comfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Balafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Lotrafilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Galyfilcon A)
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
1
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Subject Disinterest
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject Ineligible
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Discomfort
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Vistakon Investigational Multi-purpose Contact Lens Care Solution.
Baseline characteristics by cohort
| Measure |
Solution 1 (Etafilcon A)
n=40 Participants
All subjects that were dispensed solution 1 and the etafilcon A lens.
|
Solution 1 (Comfilcon A)
n=40 Participants
All subjects that were dispensed solution 1 and the comfilcon A study lens.
|
Solution 1 (Balafilcon A)
n=38 Participants
All subjects that were dispensed solution 1 and the balafilcon A study lens.
|
Solution 1 (Lotrafilcon A)
n=40 Participants
All subjects that were dispensed solution 1 and the lotrafilcon A study lens.
|
Solution 1 (Galyfilcon A)
n=41 Participants
All subjects that were dispensed solution 1 and the galyfilcon A study lens.
|
Solution 2 (Etafilcon A)
n=18 Participants
All subjects that were dispensed solution 2 and etafilcon A study lens.
|
Solution 2 (Comfilcon A)
n=19 Participants
All subjects that were dispensed solution 2 and the comfilcon A study lens.
|
Solution 2 (Balafilcon A)
n=19 Participants
All subjects that were dispensed solution 2 and balafilcon A study lens.
|
Solution 2 (Lotrafilcon A)
n=20 Participants
All subjects that were dispensed solution 2 and the lotrafilcon A study lens.
|
Solution 2 (Galyfilcon A)
n=20 Participants
All subjects that were dispensed solution 2 and the galyfilcon A study lens.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Solution 1(etafilcon A)
|
30.17 years
STANDARD_DEVIATION 8.692 • n=5 Participants
|
31.58 years
STANDARD_DEVIATION 9.459 • n=7 Participants
|
32.16 years
STANDARD_DEVIATION 8.526 • n=5 Participants
|
29.45 years
STANDARD_DEVIATION 9.333 • n=4 Participants
|
29.10 years
STANDARD_DEVIATION 7.993 • n=21 Participants
|
32.48 years
STANDARD_DEVIATION 7.845 • n=10 Participants
|
29.95 years
STANDARD_DEVIATION 6.417 • n=115 Participants
|
34.26 years
STANDARD_DEVIATION 8.738 • n=6 Participants
|
30.10 years
STANDARD_DEVIATION 9.554 • n=6 Participants
|
32.15 years
STANDARD_DEVIATION 8.079 • n=64 Participants
|
30.89 years
STANDARD_DEVIATION 9.012 • n=17 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
189 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
11 Participants
n=64 Participants
|
106 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
38 participants
n=5 Participants
|
40 participants
n=4 Participants
|
41 participants
n=21 Participants
|
18 participants
n=10 Participants
|
19 participants
n=115 Participants
|
19 participants
n=6 Participants
|
20 participants
n=6 Participants
|
20 participants
n=64 Participants
|
295 participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months Post Lens WearPopulation: All subjects that completed the study.
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Outcome measures
| Measure |
Solution1 (Etafilcon A)
n=78 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Comfilcon A)
n=78 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Balafilcon A)
n=72 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Lotrafilcon A)
n=74 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Galyfilcon A)
n=76 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution2 (Etafilcon A)
n=30 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Comfilcon A)
n=36 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Balafilcon A)
n=36 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Lotrafilcon A)
n=40 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Galyfilcon A)
n=38 Subject eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Slit Lamp Findings (SLF)
Edema
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
|
Slit Lamp Findings (SLF)
Other Findings
|
6 eyes (2 per subject)
|
3 eyes (2 per subject)
|
1 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
|
Slit Lamp Findings (SLF)
Corneal Neovascularization
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
0 eyes (2 per subject)
|
|
Slit Lamp Findings (SLF)
Corneal Staining
|
8 eyes (2 per subject)
|
16 eyes (2 per subject)
|
14 eyes (2 per subject)
|
12 eyes (2 per subject)
|
6 eyes (2 per subject)
|
8 eyes (2 per subject)
|
3 eyes (2 per subject)
|
28 eyes (2 per subject)
|
12 eyes (2 per subject)
|
8 eyes (2 per subject)
|
|
Slit Lamp Findings (SLF)
Injection
|
1 eyes (2 per subject)
|
0 eyes (2 per subject)
|
1 eyes (2 per subject)
|
0 eyes (2 per subject)
|
3 eyes (2 per subject)
|
1 eyes (2 per subject)
|
2 eyes (2 per subject)
|
4 eyes (2 per subject)
|
0 eyes (2 per subject)
|
3 eyes (2 per subject)
|
|
Slit Lamp Findings (SLF)
Tarsal Abnormalities
|
15 eyes (2 per subject)
|
10 eyes (2 per subject)
|
10 eyes (2 per subject)
|
10 eyes (2 per subject)
|
2 eyes (2 per subject)
|
0 eyes (2 per subject)
|
1 eyes (2 per subject)
|
6 eyes (2 per subject)
|
9 eyes (2 per subject)
|
1 eyes (2 per subject)
|
PRIMARY outcome
Timeframe: Up to 3 Months Post Lens WearPopulation: All subjects that completed the study.
Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.
Outcome measures
| Measure |
Solution1 (Etafilcon A)
n=78 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Comfilcon A)
n=78 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Balafilcon A)
n=72 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Lotrafilcon A)
n=74 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Galyfilcon A)
n=76 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution2 (Etafilcon A)
n=30 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Comfilcon A)
n=36 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Balafilcon A)
n=36 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Lotrafilcon A)
n=40 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Galyfilcon A)
n=38 Subjects Eyes
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Distance Visual Acuity (LogMAR)
2-week
|
-0.045 LogMAR
Standard Deviation 0.0642
|
-0.041 LogMAR
Standard Deviation 0.0663
|
-0.047 LogMAR
Standard Deviation 0.0592
|
-0.039 LogMAR
Standard Deviation 0.0649
|
-0.037 LogMAR
Standard Deviation 0.0594
|
-0.058 LogMAR
Standard Deviation 0.0585
|
-0.045 LogMAR
Standard Deviation 0.0642
|
-0.051 LogMAR
Standard Deviation 0.0625
|
-0.031 LogMAR
Standard Deviation 0.0551
|
-0.030 LogMAR
Standard Deviation 0.0595
|
|
Distance Visual Acuity (LogMAR)
1-week
|
-0.033 LogMAR
Standard Deviation 0.0601
|
-0.042 LogMAR
Standard Deviation 0.0630
|
-0.037 LogMAR
Standard Deviation 0.0563
|
-0.040 LogMAR
Standard Deviation 0.0665
|
-0.029 LogMAR
Standard Deviation 0.0615
|
-0.055 LogMAR
Standard Deviation 0.0580
|
-0.033 LogMAR
Standard Deviation 0.0601
|
-0.040 LogMAR
Standard Deviation 0.0540
|
-0.045 LogMAR
Standard Deviation 0.0685
|
-0.012 LogMAR
Standard Deviation 0.0619
|
|
Distance Visual Acuity (LogMAR)
1-Month
|
-0.045 LogMAR
Standard Deviation 0.0623
|
-0.042 LogMAR
Standard Deviation 0.0644
|
-0.033 LogMAR
Standard Deviation 0.0658
|
-0.040 LogMAR
Standard Deviation 0.0628
|
-0.037 LogMAR
Standard Deviation 0.0595
|
-0.068 LogMAR
Standard Deviation 0.0541
|
-0.045 LogMAR
Standard Deviation 0.0623
|
-0.026 LogMAR
Standard Deviation 0.0534
|
-0.031 LogMAR
Standard Deviation 0.0626
|
-0.032 LogMAR
Standard Deviation 0.0610
|
|
Distance Visual Acuity (LogMAR)
3-Month
|
-0.045 LogMAR
Standard Deviation 0.0673
|
-0.031 LogMAR
Standard Deviation 0.0609
|
-0.039 LogMAR
Standard Deviation 0.0617
|
-0.038 LogMAR
Standard Deviation 0.0607
|
-0.031 LogMAR
Standard Deviation 0.0613
|
-0.051 LogMAR
Standard Deviation 0.0668
|
-0.045 LogMAR
Standard Deviation 0.0673
|
-0.034 LogMAR
Standard Deviation 0.0567
|
-0.014 LogMAR
Standard Deviation 0.0618
|
-0.040 LogMAR
Standard Deviation 0.0614
|
Adverse Events
Solution1 (Etafilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Solution1 (Comfilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Solution1 (Balafilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Solution1 (Lotrafilcon A)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Solution1 (Galyfilcon A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Solution2 (Etafilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Solution2 (Comfilcon A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Solution2 (Balafilcon A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Solution2 (Lotrafilcon A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Solution2 (Galyfilcon A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Solution1 (Etafilcon A)
n=40 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Comfilcon A)
n=40 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Balafilcon A)
n=38 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Lotrafilcon A)
n=40 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Galyfilcon A)
n=41 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution2 (Etafilcon A)
n=18 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Comfilcon A)
n=19 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Balafilcon A)
n=19 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Lotrafilcon A)
n=20 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Galyfilcon A)
n=20 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Vitreous Hemorrhage / Retinal Detachment
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/38 • Throughout the duration of the study. Approximately 3 months.
|
2.5%
1/40 • Number of events 1 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/41 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/18 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/20 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/20 • Throughout the duration of the study. Approximately 3 months.
|
Other adverse events
| Measure |
Solution1 (Etafilcon A)
n=40 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Comfilcon A)
n=40 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Balafilcon A)
n=38 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Lotrafilcon A)
n=40 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution1 (Galyfilcon A)
n=41 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
|
Solution2 (Etafilcon A)
n=18 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Comfilcon A)
n=19 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Balafilcon A)
n=19 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Lotrafilcon A)
n=20 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
Solution2 (Galyfilcon A)
n=20 participants at risk
Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis - Bacterial
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/38 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
2.4%
1/41 • Number of events 1 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/18 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 3 months.
|
5.3%
1/19 • Number of events 2 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/20 • Throughout the duration of the study. Approximately 3 months.
|
5.0%
1/20 • Number of events 1 • Throughout the duration of the study. Approximately 3 months.
|
|
Eye disorders
Symptoms/ Complaints
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/38 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/40 • Throughout the duration of the study. Approximately 3 months.
|
2.4%
1/41 • Number of events 2 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/18 • Throughout the duration of the study. Approximately 3 months.
|
5.3%
1/19 • Number of events 2 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/19 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/20 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/20 • Throughout the duration of the study. Approximately 3 months.
|
Additional Information
Kristy Canavan, O.D.- PRINCIPAL RESEARCH OPTOMETRIST, Clin Ops
Johson & Johnson Vision Care Inc.
Phone: 904-443-3500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60