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Mucin Balls and Corneal Inflammation Events

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01437319
First received: September 16, 2011
Last updated: January 28, 2016
Last verified: January 2016
Results First Received: November 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Corneal Inflammation
Corneal Infiltrative Events
Interventions: Device: lotrafilcon A
Device: comfilcon A
Device: balafilcon A
Other: etafilcon A

  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
289 Subjects were enrolled in the study. 7 subjects did not meet the eligibility criteria. 282 subjects entered Phase I. During Phase I, 55 subjects were either lost to follow-up or discontinued. The remaining 227 subjects were randomized to either comfilcon A or balafilcon A and entered Phase II. 146 subjects completed Phase II

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During Phase I, subjects are classified as either repeated Mucin Ball former or Non-Repeat Mucin Ball former. The 227 subjects that entered Phase II kept there Mucin ball classification, but were still randomized to either comfilcon A or balafilcon A. All comparisons are made between Mucin Ball classification

Reporting Groups
  Description
Lotrafilcon A All subjects received lotrafilcon A in Phase I.
Comfilcon A Subjects that received comfilcon A lens in Phase II.
Balfilcon A Subjects that received balafilcon A lens in Phase II.

Participant Flow for 2 periods

Period 1:   Phase I
    Lotrafilcon A   Comfilcon A   Balfilcon A
STARTED   282   0   0 
COMPLETED   227   0   0 
NOT COMPLETED   55   0   0 
Lost to Follow-up                2                0                0 
Protocol Violation                1                0                0 
Study related symptoms/complaints                27                0                0 
Withdrawal by Subject                25                0                0 

Period 2:   Phase II
    Lotrafilcon A   Comfilcon A   Balfilcon A
STARTED   0   115   112 
COMPLETED   0   71   75 
NOT COMPLETED   0   44   37 
Withdrawal by Subject                0                8                16 
Lost to Follow-up                0                7                2 
Study related symptoms/complaints                0                28                19 
Protocol Violation                0                1                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.
The analysis population consists of all subjects that entered Phase 1.

Reporting Groups
  Description
Overall The analysis population consists of all subjects that were enrolled into the study.

Baseline Measures
   Overall 
Overall Participants Analyzed 
[Units: Participants]
 282 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.8  (11.6) 
Gender 
[Units: Participants]
 
Female   182 
Male   100 
Region of Enrollment 
[Units: Participants]
 
United States   282 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Corneal Infiltrate Events - Phase I   [ Time Frame: 1-Month Follow-up ]

2.  Primary:   Corneal Infiltrate Event- Phase II   [ Time Frame: 12-Month Follow-up ]


  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: Tawnya Wilson, OD Principal Research Optometrist
Organization: Johnson &Johnson Vision Care, Inc
phone: 904-443-3500 ext 1834
e-mail: TWilson@ITS.JNJ.com



Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01437319     History of Changes
Other Study ID Numbers: CR-005016
Study First Received: September 16, 2011
Results First Received: November 16, 2015
Last Updated: January 28, 2016
Health Authority: United States: Institutional Review Board