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Investigational Multi-purpose Contact Lens Care Solution.

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ClinicalTrials.gov Identifier: NCT01055613
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : August 31, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Contact Lens Wear
Interventions Device: Vistakon Investigational Multi-Purpose Solution I
Device: ReNu MultiPlus Multi-Purpose Solution
Enrollment 312

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Experimental Multi-purpose Solution ReNu MultiPlus Multi-Purpose Solution
Hide Arm/Group Description Experimental multi-purpose contact lens care solution (Test treatment) Marketed multi-purpose contact lens care solution (Control Treatment).
Period Title: Overall Study
Started 200 100
Completed 191 96
Not Completed 9 4
Reason Not Completed
No Longer Meets Eligibility Criteria             3             0
Unacceptable lens fit             1             0
Discomfort             2             1
Lost to Follow-up             1             1
Protocol Violation             1             1
Subject Disinterest             1             1
Arm/Group Title Experimental Mutli-purpose Solution ReNu Multi-purpose Solution Total
Hide Arm/Group Description Experimental multi-purpose solution (Test treatment) . Marketed multi-purpose solution (Control Treatment). Total of all reporting groups
Overall Number of Baseline Participants 200 100 300
Hide Baseline Analysis Population Description
All subjects that were dispensed a study lens.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 100 participants 300 participants
32.40  (9.231) 31.05  (8.624) 31.73  (8.928)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 100 participants 300 participants
Female
145
  72.5%
71
  71.0%
216
  72.0%
Male
55
  27.5%
29
  29.0%
84
  28.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants 100 participants 300 participants
Black or African American 5 6 11
Native Hawaiian or other Island Pacificer 0 1 1
Asian 3 2 5
White 185 88 273
Other 6 3 9
American Indian or Native Alaskian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 200 participants 100 participants 300 participants
200 100 300
1.Primary Outcome
Title Slit Lamp Findings
Hide Description 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.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all subjects that were dispensed a solution during the course of the study.
Arm/Group Title Experimental Multi-purpose Solution ReNu MultiPlus Multi-Purpose Solution
Hide Arm/Group Description:
Experimental multi-purpose contact lens care solution (Test treatment)
Marketed multi-purpose contact lens care solution (Control Treatment).
Overall Number of Participants Analyzed 191 96
Overall Number of Units Analyzed
Type of Units Analyzed: Subject Eye's
382 192
Measure Type: Number
Unit of Measure: Subjects Eyes
Corneal Staining 11 16
Conjunctival Staining 0 0
Tarsal Abnormalities 14 12
2.Primary Outcome
Title Distance Visual Acuity (LogMAR)
Hide Description 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.
Time Frame Up to 3 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Experimental Multi-purpose Solution ReNu MultiPlus Multi-Purpose Solution
Hide Arm/Group Description:
Experimental multi-purpose contact lens care solution (Test treatment)
Marketed multi-purpose contact lens care solution (Control Treatment).
Overall Number of Participants Analyzed 191 96
Overall Number of Units Analyzed
Type of Units Analyzed: Subject Eyes
382 192
Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.030  (0.0639) -0.031  (0.0634)
Time Frame Throughout the duration of the study. Approximately 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Multi-purpose Solution ReNu MultiPlus Multi-Purpose Solution
Hide Arm/Group Description Experimental multi-purpose contact lens care solution (Test treatment) Marketed multi-purpose contact lens care solution (Control Treatment).
All-Cause Mortality
Experimental Multi-purpose Solution ReNu MultiPlus Multi-Purpose Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Multi-purpose Solution ReNu MultiPlus Multi-Purpose Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/200 (0.50%)      0/100 (0.00%)    
Eye disorders     
Microbial Keratitis  1/200 (0.50%)  1 0/100 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental Multi-purpose Solution ReNu MultiPlus Multi-Purpose Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/200 (0.00%)      0/100 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Brian Pall, O.D.- Research Principle Optometrist
Organization: Johnson & Johnson Vision Care Inc.
Phone: 904-443-1290
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01055613     History of Changes
Other Study ID Numbers: CR-1624
First Submitted: January 22, 2010
First Posted: January 25, 2010
Results First Submitted: June 7, 2016
Results First Posted: August 31, 2016
Last Update Posted: June 19, 2018