Investigational Multi-purpose Contact Lens Care Solution.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01055613
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : August 31, 2016
Last Update Posted : June 19, 2018
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

  Participant Flow

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
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 
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

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
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 
[Units: Years]
Mean (Standard Deviation)
 32.40  (9.231)   31.05  (8.624)   31.73  (8.928) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      145  72.5%      71  71.0%      216  72.0% 
Male      55  27.5%      29  29.0%      84  28.0% 
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

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

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

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

Responsible Party: Johnson & Johnson Vision Care, Inc. 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