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Investigational Multi-purpose Contact Lens Care Solution.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01055613
First received: January 22, 2010
Last updated: July 18, 2016
Last verified: July 2016
Results First Received: June 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Contact Lens Wear
Interventions: Device: Vistakon Investigational Multi-Purpose Solution I
Device: ReNu MultiPlus Multi-Purpose Solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Experimental Multi-purpose Solution   ReNu MultiPlus Multi-Purpose Solution
STARTED   200   100 
COMPLETED   191   96 
NOT COMPLETED   9   4 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects that were dispensed a study lens.

Reporting Groups
  Description
Experimental Mutli-purpose Solution Experimental multi-purpose solution (Test treatment) .
ReNu Multi-purpose Solution Marketed multi-purpose solution (Control Treatment).
Total Total of all reporting groups

Baseline Measures
   Experimental Mutli-purpose Solution   ReNu Multi-purpose Solution   Total 
Overall Participants Analyzed 
[Units: Participants]
 200   100   300 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.40  (9.231)   31.05  (8.624)   31.73  (8.928) 
Gender 
[Units: Participants]
     
Female   145   71   216 
Male   55   29   84 
Race/Ethnicity, Customized 
[Units: 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 
[Units: Participants]
     
United States   200   100   300 


  Outcome Measures
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1.  Primary:   Slit Lamp Findings   [ Time Frame: 3 months ]

2.  Primary:   Distance Visual Acuity (LogMAR)   [ Time Frame: Up to 3 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: BPALL@its.jnj.com



Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01055613     History of Changes
Other Study ID Numbers: CR-1624
Study First Received: January 22, 2010
Results First Received: June 7, 2016
Last Updated: July 18, 2016
Health Authority: United States: Institutional Review Board