Trial Outcomes & Findings for Investigational Multi-purpose Contact Lens Care Solution. (NCT NCT01055613)
NCT ID: NCT01055613
Last Updated: 2018-06-19
Results Overview
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.
COMPLETED
NA
312 participants
3 months
2018-06-19
Participant Flow
A total of 312 subjects were enrolled in this study. Of the enrolled subjects 12 did not meet the eligibility criteria and 300 were randomized to treatment using an allocation of 2:1 for test and control, respectively. Of the 300 randomized subjects 13 were discontinued from the study and 287 subjects completed the study.
Participant milestones
| Measure |
Experimental Multi-purpose Solution
Experimental multi-purpose contact lens care solution (Test treatment)
|
ReNu MultiPlus Multi-Purpose Solution
Marketed multi-purpose contact lens care solution (Control Treatment).
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
100
|
|
Overall Study
COMPLETED
|
191
|
96
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Experimental Multi-purpose Solution
Experimental multi-purpose contact lens care solution (Test treatment)
|
ReNu MultiPlus Multi-Purpose Solution
Marketed multi-purpose contact lens care solution (Control Treatment).
|
|---|---|---|
|
Overall Study
No Longer Meets Eligibility Criteria
|
3
|
0
|
|
Overall Study
Unacceptable lens fit
|
1
|
0
|
|
Overall Study
Discomfort
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Subject Disinterest
|
1
|
1
|
Baseline Characteristics
Investigational Multi-purpose Contact Lens Care Solution.
Baseline characteristics by cohort
| Measure |
Experimental Mutli-purpose Solution
n=200 Participants
Experimental multi-purpose solution (Test treatment) .
|
ReNu Multi-purpose Solution
n=100 Participants
Marketed multi-purpose solution (Control Treatment).
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.40 years
STANDARD_DEVIATION 9.231 • n=99 Participants
|
31.05 years
STANDARD_DEVIATION 8.624 • n=107 Participants
|
31.73 years
STANDARD_DEVIATION 8.928 • n=206 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Island Pacificer
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
185 participants
n=99 Participants
|
88 participants
n=107 Participants
|
273 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Native Alaskian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=99 Participants
|
100 participants
n=107 Participants
|
300 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The analysis population consists of all subjects that were dispensed a solution during the course of the study.
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.
Outcome measures
| Measure |
Experimental Multi-purpose Solution
n=382 Subject Eye's
Experimental multi-purpose contact lens care solution (Test treatment)
|
ReNu MultiPlus Multi-Purpose Solution
n=192 Subject Eye's
Marketed multi-purpose contact lens care solution (Control Treatment).
|
|---|---|---|
|
Slit Lamp Findings
Corneal Staining
|
11 Subjects Eyes
|
16 Subjects Eyes
|
|
Slit Lamp Findings
Conjunctival Staining
|
0 Subjects Eyes
|
0 Subjects Eyes
|
|
Slit Lamp Findings
Tarsal Abnormalities
|
14 Subjects Eyes
|
12 Subjects Eyes
|
PRIMARY outcome
Timeframe: Up to 3 MonthsPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation.
Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.
Outcome measures
| Measure |
Experimental Multi-purpose Solution
n=382 Subject Eyes
Experimental multi-purpose contact lens care solution (Test treatment)
|
ReNu MultiPlus Multi-Purpose Solution
n=192 Subject Eyes
Marketed multi-purpose contact lens care solution (Control Treatment).
|
|---|---|---|
|
Distance Visual Acuity (LogMAR)
|
-0.030 LogMAR
Standard Deviation 0.0639
|
-0.031 LogMAR
Standard Deviation 0.0634
|
Adverse Events
Experimental Multi-purpose Solution
ReNu MultiPlus Multi-Purpose Solution
Serious adverse events
| Measure |
Experimental Multi-purpose Solution
n=200 participants at risk
Experimental multi-purpose contact lens care solution (Test treatment)
|
ReNu MultiPlus Multi-Purpose Solution
n=100 participants at risk
Marketed multi-purpose contact lens care solution (Control Treatment).
|
|---|---|---|
|
Eye disorders
Microbial Keratitis
|
0.50%
1/200 • Number of events 1 • Throughout the duration of the study. Approximately 3 months.
|
0.00%
0/100 • Throughout the duration of the study. Approximately 3 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Brian Pall, O.D.- Research Principle Optometrist
Johnson & Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60