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Mucin Balls and Corneal Inflammation Events

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ClinicalTrials.gov Identifier: NCT01437319
Recruitment Status : Completed
First Posted : September 20, 2011
Results First Posted : February 25, 2016
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: 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
Enrollment 289
Recruitment Details 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 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
Arm/Group Title Lotrafilcon A Comfilcon A Balfilcon A
Hide Arm/Group Description All subjects received lotrafilcon A in Phase I. Subjects that received comfilcon A lens in Phase II. Subjects that received balafilcon A lens in Phase II.
Period Title: Phase I
Started 282 0 0
Completed 227 0 0
Not Completed 55 0 0
Reason Not Completed
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 Title: Phase II
Started 0 115 112
Completed 0 71 75
Not Completed 0 44 37
Reason Not Completed
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
Arm/Group Title Overall
Hide Arm/Group Description The analysis population consists of all subjects that were enrolled into the study.
Overall Number of Baseline Participants 282
Hide Baseline Analysis Population Description
The analysis population consists of all subjects that entered Phase 1.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 282 participants
33.8  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants
Female
182
  64.5%
Male
100
  35.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 282 participants
282
1.Primary Outcome
Title Corneal Infiltrate Events - Phase I
Hide Description The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Time Frame 1-Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective.
Arm/Group Title Repeat Mucin Ball Former Non-repeat Mucin Ball Former
Hide Arm/Group Description:
Subjects that were classified as being repeat Mucin Ball former.
Subjects that were classified as Non-repeat Mucin Ball Former.
Overall Number of Participants Analyzed 161 53
Measure Type: Number
Unit of Measure: percentage of subjects
18.6 5.7
2.Primary Outcome
Title Corneal Infiltrate Event- Phase II
Hide Description The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Time Frame 12-Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification.
Arm/Group Title Repeat Mucin Ball Former Non-repeat Mucin Ball Former
Hide Arm/Group Description:
Subjects that were classified as being repeat Mucin Ball former
Subjects that were classified as Non-repeat Mucin Ball Former
Overall Number of Participants Analyzed 153 43
Measure Type: Number
Unit of Measure: percentage of subjects
balafilcon A, N=66, N=28 4.5 3.6
comfilcon A, N=87, N=15 14.9 33.3
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Comfilcon A Balafilcon A Lotrafilcon A
Hide Arm/Group Description Subjects who received comfilcon A in Phase II of the study. Subjects who received balafilcon A in Phase II of the study All Subjects received lotrafilcon A in Phase I of the study.
All-Cause Mortality
Comfilcon A Balafilcon A Lotrafilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Comfilcon A Balafilcon A Lotrafilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/115 (0.00%)      0/112 (0.00%)      0/282 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Comfilcon A Balafilcon A Lotrafilcon A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/115 (26.09%)      24/112 (21.43%)      23/282 (8.16%)    
Eye disorders       
Asymptomatic corneal scar  6/114 (5.26%)  6 3/112 (2.68%)  3 3/282 (1.06%)  3
Cornea Lens Peripheral Ulcer (CLPU)  12/115 (10.43%)  13 3/112 (2.68%)  3 10/282 (3.55%)  10
Conjunctivitis [1]  12/115 (10.43%)  25 12/112 (10.71%)  21 8/282 (2.84%)  12
SEALs  0/115 (0.00%)  0 6/112 (5.36%)  6 2/282 (0.71%)  4
[1]
Includes Contact lens papillary, viral, bacterial, and allergic
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.
Results Point of Contact
Name/Title: Tawnya Wilson, OD Principal Research Optometrist
Organization: Johnson &Johnson Vision Care, Inc
Phone: 904-443-3500 ext 1834
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov 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