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Daily Wear Corneal Infiltrative Event Study (DWCIE)

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ClinicalTrials.gov Identifier: NCT00937105
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Loretta Szczotka-Flynn, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Myopia
Hyperopia
Corneal Infiltrative Events
Interventions Device: lotrafilcon A contact lenses
Device: Renu Multiplus
Device: Clear Care
Enrollment 218
Recruitment Details From November 2009 to February 2012, 218 participants were randomized at the University Hospitals Case Medical Center Eye Institute.
Pre-assignment Details Existing soft lens wearers or non contact lens wearers were recruited, no wash out period was required
Arm/Group Title Lotrafilcon A Lenses and Clear Care Lotrafilcon A Lenses and Renu Multiplus
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 109 109
Completed 69 70
Not Completed 40 39
Arm/Group Title Lotrafilcon A and Renu Lotrafilcon A and Clear Care Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 109 109 218
Hide Baseline Analysis Population Description
The baseline measures refer to the entire cohort of 218 participants that were randomized, stratified by solution group
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 109 participants 218 participants
<=18 years
1
   0.9%
2
   1.8%
3
   1.4%
Between 18 and 65 years
108
  99.1%
107
  98.2%
215
  98.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 109 participants 218 participants
34.4  (11.3) 34.9  (11.5) 34.7  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 109 participants 218 participants
Female
78
  71.6%
75
  68.8%
153
  70.2%
Male
31
  28.4%
34
  31.2%
65
  29.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants 109 participants 218 participants
109 109 218
1.Primary Outcome
Title Number of Participants Developing a Corneal Inflammatory Event (CIE)
Hide Description Raw number of participants in each solution arm developing CIE over 12 month follow-up period
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.
Arm/Group Title Lotrafilcon A Lenses and Renu Lotrafilcon A Lenses and Clear Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 109 109
Measure Type: Number
Unit of Measure: participants
6 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lotrafilcon A Lenses and Renu, Lotrafilcon A Lenses and Clear Care
Comments Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Kaplan-Meier
Comments Cumulative Unadjusted Probability of remaining CIE-free presented for entire cohort (both solution groups) to remain consistent with the primary aim
Method of Estimation Estimation Parameter Cumulative Probability of no-CIE
Estimated Value 92.8
Confidence Interval (2-Sided) 95%
88.6 to 96.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With CIE Stratified by Microbial Bioburden on Lenses
Hide Description Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in which valid lens bioburden data was available
Arm/Group Title Participants With Microbial Bioburden on Lenses Participants Without Microbial Bioburden on Lenses
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 53 139
Measure Type: Number
Unit of Measure: participants
4 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Microbial Bioburden on Lenses, Participants Without Microbial Bioburden on Lenses
Comments To determine if microbial contamination of lenses is a risk factor for CIE
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3923
Comments [Not Specified]
Method Regression, Cox
Comments Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.737
Confidence Interval (2-Sided) 95%
0.49 to 6.156
Estimation Comments referent is no substantial lens bioburden
3.Secondary Outcome
Title Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.
Hide Description Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with valid presumed solution induced corneal staining data in each group
Arm/Group Title Participants With Corneal Staining Participants Without Corneal Staining
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 145
Measure Type: Number
Unit of Measure: participants
2 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Corneal Staining, Participants Without Corneal Staining
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7943
Comments [Not Specified]
Method Regression, Cox
Comments Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.316
Confidence Interval (2-Sided) 95%
0.167 to 10.393
Estimation Comments referent is no corneal staining
4.Secondary Outcome
Title Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases
Hide Description Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in which valid lens case bioburden data was available
Arm/Group Title Participants With Microbial Bioburden on Lens Cases Participants With no Microbial Bioburden on Lens Cases
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 119 51
Measure Type: Number
Unit of Measure: participants
5 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Microbial Bioburden on Lens Cases, Participants With no Microbial Bioburden on Lens Cases
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5894
Comments [Not Specified]
Method Regression, Cox
Comments Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.674
Confidence Interval (2-Sided) 95%
0.161 to 2.822
Estimation Comments referent is no substantial case bioburden
5.Secondary Outcome
Title Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins
Hide Description Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in which valid lens bioburden data was available
Arm/Group Title Participants With Microbial Bioburden on Lid Margins Participants With no Microbial Bioburden on Lid Margins
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 154 40
Measure Type: Number
Unit of Measure: participants
10 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With Microbial Bioburden on Lid Margins, Participants With no Microbial Bioburden on Lid Margins
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1742
Comments Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.406
Confidence Interval (2-Sided) 95%
0.678 to 8.537
Estimation Comments referent is no substantial overall lid bioburden
6.Secondary Outcome
Title Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins
Hide Description Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in which valid lids bioburden data was available
Arm/Group Title Participants With CNS Bioburden on Lid Margins Participants With no CNS Bioburden on Lid Margins
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 84 110
Measure Type: Number
Unit of Measure: participants
8 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants With CNS Bioburden on Lid Margins, Participants With no CNS Bioburden on Lid Margins
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Cox
Comments Multivariate model adjusted for solution, gender and age
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 5.22
Confidence Interval (2-Sided) 95%
1.10 to 24.70
Estimation Comments referent is no substantial CNS lid bioburden
Time Frame up to 1 year
Adverse Event Reporting Description

CIE definitions adopted from the standards as listed in the “Institute for Eye Research/L.V. Prasad Eye Institute (IER/LVPEI) Guide To Corneal Infiltrative Conditions

Contact Lens Papillary Conjunctivitis was a clinical diagnosis that required temporary or permanent discontinuation of lens wear due to large papilla upon upper lid eversion

 
Arm/Group Title Entire Cohort of Lotrafilcon A Users
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Entire Cohort of Lotrafilcon A Users
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Entire Cohort of Lotrafilcon A Users
Affected / at Risk (%)
Total   1/218 (0.46%) 
Eye disorders   
microbial keratitis  1/218 (0.46%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Entire Cohort of Lotrafilcon A Users
Affected / at Risk (%)
Total   23/218 (10.55%) 
Eye disorders   
corneal infiltrative event  12/218 (5.50%) 
Contact Lens Papillary Conjunctivitis  11/218 (5.05%) 
Mostly asymptomatic CIE events occurred which limited the ability to retrieve the lens worn (for culture) precisely at the time of CIE development; this may have hindered our ability to capture bioburden at the time of the adverse event.
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
Layout table for Results Point of Contact information
Name/Title: Loretta Szczotka-Flynn OD, PhD
Organization: University Hospitals Eye Institute
Phone: 216-844-3609
EMail: loretta.szczotka@uhhospitals.org
Layout table for additonal information
Responsible Party: Loretta Szczotka-Flynn, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00937105    
Other Study ID Numbers: 001
First Submitted: July 9, 2009
First Posted: July 10, 2009
Results First Submitted: July 1, 2013
Results First Posted: March 10, 2014
Last Update Posted: March 10, 2014