Mucin Balls and Corneal Inflammation Events

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: NCT01437319
Recruitment Status : Completed
First Posted : September 20, 2011
Results First Posted : February 25, 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: None (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

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
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

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 33.8  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      182  64.5% 
Male      100  35.5% 
Region of Enrollment 
[Units: Participants]
United States   282 

  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

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: Tawnya Wilson, OD Principal Research Optometrist
Organization: Johnson &Johnson Vision Care, Inc
phone: 904-443-3500 ext 1834

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

Responsible Party: Johnson & Johnson Vision Care, Inc. Identifier: NCT01437319     History of Changes
Other Study ID Numbers: CR-005016
First Submitted: September 16, 2011
First Posted: September 20, 2011
Results First Submitted: November 16, 2015
Results First Posted: February 25, 2016
Last Update Posted: June 19, 2018