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Vistakon 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:
NCT01055457
First received: January 22, 2010
Last updated: November 28, 2016
Last verified: November 2016
Results First Received: August 10, 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 II
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
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.

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

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Solution1 (Etafilcon A)   Solution1 (Comfilcon A)   Solution1 (Balafilcon A)   Solution1 (Lotrafilcon A)   Solution1 (Galyfilcon A)   Solution2 (Etafilcon A)   Solution2 (Comfilcon A)   Solution2 (Balafilcon A)   Solution2 (Lotrafilcon A)   Solution2 (Galyfilcon A)
STARTED   40   40   38   40   41   18   19   19   20   20 
COMPLETED   39   39   36   37   38   15   18   18   20   19 
NOT COMPLETED   1   1   2   3   3   3   1   1   0   1 
Lost to Follow-up                0                1                0                0                0                1                0                0                0                0 
Protocol Violation                0                0                1                1                1                2                1                0                0                1 
Subject Disinterest                0                0                0                0                0                0                0                1                0                0 
Subject Ineligible                1                0                1                0                1                0                0                0                0                0 
Discomfort                0                0                0                0                1                0                0                0                0                0 
Pregnancy                0                0                0                1                0                0                0                0                0                0 
Adverse Event                0                0                0                1                0                0                0                0                0                0 



  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 and solution.

Reporting Groups
  Description
Dispensed Subjects All subjects that were dispensed a study lens and solution.

Baseline Measures
   Dispensed Subjects 
Overall Participants Analyzed 
[Units: Participants]
 295 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Solution 1(etafilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 1(etafilcon A)   30.17  (8.692) 
Solution 1(comfilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 1(comfilcon A)   31.58  (9.459) 
Solution 1(balafilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 1(balafilcon A)   32.16  (8.526) 
Solution 1(lotrafilcon B)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 1(lotrafilcon B)   29.45  (9.333) 
Solution 1(galyfilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 1(galyfilcon A)   29.10  (7.993) 
Solution 2 (etafilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 2 (etafilcon A)   32.48  (7.845) 
Solution 2(comfilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 2(comfilcon A)   29.95  (6.417) 
Solution 2(balafilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 2(balafilcon A)   34.26  (8.738) 
Solution 2(lotrafilcon B)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 2(lotrafilcon B)   30.10  (9.554) 
Solution 2(galyfilcon A)   
Participants Analyzed 
[Units: Participants]
 295 
Solution 2(galyfilcon A)   32.15  (8.079) 
Gender [1] 
[Units: Participants]
Count of Participants
 
Solution 1(etafilcon A)   
Participants Analyzed 
[Units: Participants]
 40 
Female      25  62.5% 
Male      15  37.5% 
Solution 1(comfilcon A)   
Participants Analyzed 
[Units: Participants]
 40 
Female      28  70.0% 
Male      12  30.0% 
Solution 1(balafilcon A)   
Participants Analyzed 
[Units: Participants]
 38 
Female      24  63.2% 
Male      14  36.8% 
Solution 1(lotrafilcon B)   
Participants Analyzed 
[Units: Participants]
 40 
Female      25  62.5% 
Male      15  37.5% 
Solution 1(galyfilcon A)   
Participants Analyzed 
[Units: Participants]
 41 
Female      31  75.6% 
Male      10  24.4% 
Solution 2 (etafilcon A)   
Participants Analyzed 
[Units: Participants]
 18 
Female      13  72.2% 
Male      5  27.8% 
Solution 2(comfilcon A)   
Participants Analyzed 
[Units: Participants]
 19 
Female      9  47.4% 
Male      10  52.6% 
Solution 2(balafilcon A)   
Participants Analyzed 
[Units: Participants]
 19 
Female      12  63.2% 
Male      7  36.8% 
Solution 2(lotrafilcon B)   
Participants Analyzed 
[Units: Participants]
 20 
Female      13  65.0% 
Male      7  35.0% 
Solution 2(galyfilcon A)   
Participants Analyzed 
[Units: Participants]
 20 
Female      9  45.0% 
Male      11  55.0% 
[1] The row shows the distribution of gender by solution/lens combination. All the combinations together add to the overall total.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed 
[Units: Participants]
 295 
United States   295 


  Outcome Measures
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1.  Primary:   Slit Lamp Findings (SLF)   [ Time Frame: Up to 3 months Post Lens Wear ]

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


  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
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  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: Kristy Canavan, O.D.- PRINCIPAL RESEARCH OPTOMETRIST, Clin Ops
Organization: Johson & Johnson Vision Care Inc.
phone: 904-443-3500
e-mail: KCANAVA2@its.jnj.com



Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01055457     History of Changes
Other Study ID Numbers: CR-1650
Study First Received: January 22, 2010
Results First Received: August 10, 2016
Last Updated: November 28, 2016