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Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

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ClinicalTrials.gov Identifier: NCT01791517
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : November 6, 2017
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: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Contact Lens Solutions
Interventions: Other: Solution 1 (Test)
Other: Solution 2 (Test)
Other: Solution 3 (Test)
Other: Solution 4 (Control)

  Participant Flow

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 269 Subjects were enrolled into this study. Of the enrolled 33 subjects did not meet the eligibility criteria. In Phase I 28 subjects were discontinued and 208 subjects completed Phase I. Of the 208 subjects that continued into Phase II 187 subjects completed the study and 21 subjects were discontinued from the from Phase II.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were first randomized to 1 of 3 lenses(Lens A: senofilcon A, Lens B: galyfilcon A, Lens C: etafilcon A), then within each lens subjects were randomized to 1 of 12 unique solution sequences, totaling in 36 sequences. Due to such a large number of sequences for reporting purposes, subject disposition is reported by solution and period.

Reporting Groups
  Description
Biotrue/PureMoist/Revitalens/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Biotrue/RevitaLens/Clear Care/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Biotrue/Clear Care/PureMoist/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
PureMoist/Biotrue/Clear Care/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
PureMoist/RevitaLens/Biotrue/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
PureMoist/Clear Care/RevitaLens/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
RevitaLens/Biotrue/PureMoist/Clear Care Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
RevitaLens/PureMoist/Clear Care/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
RevitaLens/Clear Care/Biotrue/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Clear Care/Biotrue/RevitaLens/PureMoist Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Clear Care/PureMoist/Biotrue/RevitaLens Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.
Clear Care/RevitaLens/PureMoist/Biotrue Subjects were first randomized to receive to one of three lenses lens. For Phase I subjects were then further randomized to one of twelve unique solution sequences.

Participant Flow for 5 periods

Period 1:   Phase I: Period 1
    Biotrue/PureMoist/Revitalens/Clear Care   Biotrue/RevitaLens/Clear Care/PureMoist   Biotrue/Clear Care/PureMoist/RevitaLens   PureMoist/Biotrue/Clear Care/RevitaLens   PureMoist/RevitaLens/Biotrue/Clear Care   PureMoist/Clear Care/RevitaLens/Biotrue   RevitaLens/Biotrue/PureMoist/Clear Care   RevitaLens/PureMoist/Clear Care/Biotrue   RevitaLens/Clear Care/Biotrue/PureMoist   Clear Care/Biotrue/RevitaLens/PureMoist   Clear Care/PureMoist/Biotrue/RevitaLens   Clear Care/RevitaLens/PureMoist/Biotrue
STARTED   19   20   20   19   20   20   20   20   20   20   18   20 
COMPLETED   18   18   18   17   19   19   19   20   19   19   18   19 
NOT COMPLETED   1   2   2   2   1   1   1   0   1   1   0   1 
Withdrawal by Subject                0                1                1                0                1                1                0                0                0                0                0                0 
Adverse Event                0                0                1                1                0                0                0                0                0                0                0                0 
Unsatisfactory Lens Fitting                1                0                0                0                0                0                0                0                0                0                0                0 
Protocol Violation                0                1                0                0                0                0                0                0                0                0                0                0 
Lost to Follow-up                0                0                0                1                0                0                1                0                1                1                0                0 
Lens Handling DIfficulties                0                0                0                0                0                0                0                0                0                0                0                1 

Period 2:   Phase I: Period 2
    Biotrue/PureMoist/Revitalens/Clear Care   Biotrue/RevitaLens/Clear Care/PureMoist   Biotrue/Clear Care/PureMoist/RevitaLens   PureMoist/Biotrue/Clear Care/RevitaLens   PureMoist/RevitaLens/Biotrue/Clear Care   PureMoist/Clear Care/RevitaLens/Biotrue   RevitaLens/Biotrue/PureMoist/Clear Care   RevitaLens/PureMoist/Clear Care/Biotrue   RevitaLens/Clear Care/Biotrue/PureMoist   Clear Care/Biotrue/RevitaLens/PureMoist   Clear Care/PureMoist/Biotrue/RevitaLens   Clear Care/RevitaLens/PureMoist/Biotrue
STARTED   18   18   18   17   19   19   19   20   19   19   18   19 
COMPLETED   17   15   16   16   19   18   19   20   19   18   16   19 
NOT COMPLETED   1   3   2   1   0   1   0   0   0   1   2   0 
Unsatisfactory Lens Fit                1                0                0                0                0                0                0                0                0                0                0                0 
Protocol Violation                0                0                0                1                0                0                0                0                0                0                0                0 
Withdrawal by Subject                0                0                0                0                0                0                0                0                0                1                1                0 
Unsatisfactory Visual Response                0                0                0                0                0                0                0                0                0                0                1                0 
Lens Discomfort                0                0                0                0                0                1                0                0                0                0                0                0 
Lost to Follow-up                0                3                2                0                0                0                0                0                0                0                0                0 

Period 3:   Phase I: Period 3
    Biotrue/PureMoist/Revitalens/Clear Care   Biotrue/RevitaLens/Clear Care/PureMoist   Biotrue/Clear Care/PureMoist/RevitaLens   PureMoist/Biotrue/Clear Care/RevitaLens   PureMoist/RevitaLens/Biotrue/Clear Care   PureMoist/Clear Care/RevitaLens/Biotrue   RevitaLens/Biotrue/PureMoist/Clear Care   RevitaLens/PureMoist/Clear Care/Biotrue   RevitaLens/Clear Care/Biotrue/PureMoist   Clear Care/Biotrue/RevitaLens/PureMoist   Clear Care/PureMoist/Biotrue/RevitaLens   Clear Care/RevitaLens/PureMoist/Biotrue
STARTED   17   15   16   16   19   18   19   20   19   18   16   19 
COMPLETED   17   14   16   15   18   18   19   20   19   18   16   18 
NOT COMPLETED   0   1   0   1   1   0   0   0   0   0   0   1 
Lens Discomfort                0                0                0                0                0                0                0                0                0                0                0                1 
Lost to Follow-up                0                1                0                0                1                0                0                0                0                0                0                0 
Adverse Event                0                0                0                1                0                0                0                0                0                0                0                0 

Period 4:   Phase I: Period 4
    Biotrue/PureMoist/Revitalens/Clear Care   Biotrue/RevitaLens/Clear Care/PureMoist   Biotrue/Clear Care/PureMoist/RevitaLens   PureMoist/Biotrue/Clear Care/RevitaLens   PureMoist/RevitaLens/Biotrue/Clear Care   PureMoist/Clear Care/RevitaLens/Biotrue   RevitaLens/Biotrue/PureMoist/Clear Care   RevitaLens/PureMoist/Clear Care/Biotrue   RevitaLens/Clear Care/Biotrue/PureMoist   Clear Care/Biotrue/RevitaLens/PureMoist   Clear Care/PureMoist/Biotrue/RevitaLens   Clear Care/RevitaLens/PureMoist/Biotrue
STARTED   17   14   16   15   18   18   19   20   19   18   16   18 
COMPLETED   17   14   16   15   18   18   19   20   19   18   16   18 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0 

Period 5:   Phase II
    Biotrue/PureMoist/Revitalens/Clear Care   Biotrue/RevitaLens/Clear Care/PureMoist   Biotrue/Clear Care/PureMoist/RevitaLens   PureMoist/Biotrue/Clear Care/RevitaLens   PureMoist/RevitaLens/Biotrue/Clear Care   PureMoist/Clear Care/RevitaLens/Biotrue   RevitaLens/Biotrue/PureMoist/Clear Care   RevitaLens/PureMoist/Clear Care/Biotrue   RevitaLens/Clear Care/Biotrue/PureMoist   Clear Care/Biotrue/RevitaLens/PureMoist   Clear Care/PureMoist/Biotrue/RevitaLens   Clear Care/RevitaLens/PureMoist/Biotrue
STARTED   17   14   16   15   18   18   19   20   19   18   16   18 
COMPLETED   15   14   15   15   16   14   17   17   17   15   15   17 
NOT COMPLETED   2   0   1   0   2   4   2   3   2   3   1   1 
Lost to Follow-up                1                0                1                0                1                2                0                1                1                1                0                0 
Withdrawal by Subject                1                0                0                0                0                2                0                1                0                0                1                0 
Lack of Efficacy                0                0                0                0                1                0                0                0                0                0                0                0 
Adverse Event                0                0                0                0                0                0                2                1                0                1                0                0 
Lens Handling Difficulties                0                0                0                0                0                0                0                0                1                0                0                0 
Unsatisfactory Lens Fitting                0                0                0                0                0                0                0                0                0                1                0                0 
Pre-Existing Ocular Issue                0                0                0                0                0                0                0                0                0                0                0                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.
The analysis population consists of subjects that were randomized to 1 of 3 study lenses and 1 of 12 solution sequences.

Reporting Groups
  Description
Etafilcon A All subjects that were randomized to the study lens etafilcon A and 1 of 12 possible solution sequences.
Galyfilcon A All subjects that were randomized to the study lens galyfilcon A and 1 of 12 possible solution sequences.
Senofilcon A All subjects that were randomized to the study lens senofilcon A and 1 of 12 possible solution sequences.
Total Total of all reporting groups

Baseline Measures
   Etafilcon A   Galyfilcon A   Senofilcon A   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   78   78   236 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.33  (9.726)   30.38  (10.091)   29.78  (9.938)   30.17  (9.879) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      55  68.8%      50  64.1%      53  67.9%      158  66.9% 
Male      25  31.3%      28  35.9%      25  32.1%      78  33.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Asian   18   18   22   58 
Black or African American   9   5   6   20 
Native Hawaiian or Other Pacific Islander   0   0   1   1 
White   52   45   43   140 
Other   1   10   6   17 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Canada   28   26   26   80 
United States   26   24   27   77 
United Kingdom   26   28   25   79 


  Outcome Measures

1.  Primary:   Overall Comfort Score (Senofilcon A Lens)   [ Time Frame: 2-Week Follow-up ]

2.  Primary:   Overall Comfort Score (Galyfilcon A Lens)   [ Time Frame: 2-Week Follow-up ]

3.  Primary:   Overall Comfort Score (Etafilcon A Lens)   [ Time Frame: 2-Week Follow-up ]


  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: Chantal Coles-Brennan, PRINCIPAL RESEARCH OPTOMETRIST, Global Med Affairs
Organization: Johnson & Johnson Vision Care, Inc.
phone: 904-443-3500 ext 3449
e-mail: CColesb@ITS.JNJ.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01791517     History of Changes
Other Study ID Numbers: CR-5230
First Submitted: February 11, 2013
First Posted: February 15, 2013
Results First Submitted: August 16, 2017
Results First Posted: November 6, 2017
Last Update Posted: June 19, 2018