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Evaluation of Two Marketed Multifocal Contact Lenses

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ClinicalTrials.gov Identifier: NCT03322423
Recruitment Status : Completed
First Posted : October 26, 2017
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Visual Performance
Interventions Device: Multifocal Contact Lens 1
Device: Multifocal Contact Lens 2
Device: Spherical Contact Lens 2
Enrollment 78
Recruitment Details A total of 78 subjects were enrolled into this study. Of the enrolled all 78 were dispensed at least one study lens. Of the dispensed subjects 71 completed the study, while 7 subjects were discontinued.
Pre-assignment Details  
Arm/Group Title Delefilcon A/Nesofilcon A Nesofilcon A/Delefilcon A
Hide Arm/Group Description All subjects that were randomized to receive the delefilcon A lens during the first period of the study and the nesofilcon A lens during the second period of the study. All subjects that were randomized to receive the nesofilcon A during the first period of the study and the delefilcon A lens during the second period of the study.
Period Title: Period 1
Started 38 40
Completed 36 38
Not Completed 2 2
Reason Not Completed
Subject no longer eligible             0             1
Withdrawal by Subject             0             1
Incorrect Lens Dispensed             1             0
Unsatisfactory Lens Fitting             1             0
Period Title: Period 2
Started 36 38
Completed 35 36
Not Completed 1 2
Reason Not Completed
Dispensed incorrect lens in left eye             0             1
Protocol Violation             1             0
Subject not eligible for Pytergiumectomy             0             1
Arm/Group Title All Dispensed Subjects
Hide Arm/Group Description All subjects that were dispensed a study lens.
Overall Number of Baseline Participants 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
53.9  (7.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
61
  78.2%
Male
17
  21.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants
Asian 1
Black or African American 2
White 73
American Indian or Alaska Native 2
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 78 participants
78
 100.0%
1.Primary Outcome
Title Distance Binocular Visual Acuity
Hide Description Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Time Frame 1-Week Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Delefilcon A Nesofilcon A
Hide Arm/Group Description:
All subjects that wore the delefilcon A lens during either the first or second period of the study.
All subjects that wore the nesofilcon A lens during either the first or second period of the study.
Overall Number of Participants Analyzed 65 65
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
110 110
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.056  (0.0842) -0.075  (0.0759)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delefilcon A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed model analysis
Comments Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.
Method of Estimation Estimation Parameter Least-Square Mean Estimate
Estimated Value -0.058
Confidence Interval (2-Sided) 95%
-0.080 to -0.035
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0114
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nesofilcon A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed model analysis
Comments Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.
Method of Estimation Estimation Parameter Least-Square Mean Estimate
Estimated Value -0.076
Confidence Interval (2-Sided) 95%
-0.099 to -0.054
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0114
Estimation Comments [Not Specified]
2.Primary Outcome
Title Near Binocular Visual Acuity
Hide Description Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.
Time Frame 1-Week Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Delefilcon A Nesofilcon A
Hide Arm/Group Description:
All subjects that wore the delefilcon A lens during either the first or second period of the study.
All subjects that wore the nesofilcon A lens during either the first or second period of the study.
Overall Number of Participants Analyzed 65 65
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
110 110
Mean (Standard Deviation)
Unit of Measure: logMAR
0.143  (0.1084) 0.143  (0.1117)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delefilcon A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed model analysis
Comments Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.
Method of Estimation Estimation Parameter LS Mean Estimate
Estimated Value 0.141
Confidence Interval (2-Sided) 95%
0.112 to 0.170
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0147
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nesofilcon A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed model analysis
Comments Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.
Method of Estimation Estimation Parameter LS Mean Estimate
Estimated Value 0.141
Confidence Interval (2-Sided) 95%
0.112 to 0.170
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0147
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Quality of Vision
Hide Description Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time Frame 1-Week Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Delefilcon A Nesofilcon A
Hide Arm/Group Description:
All subjects that wore the delefilcon A lens during either the first or second period of the study.
All subjects that wore the nesofilcon A lens during either the first or second period of the study.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: Units on a scale
47.4  (17.81) 49.3  (19.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delefilcon A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear Mixed Model Analysis
Comments Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.
Method of Estimation Estimation Parameter LS Mean Estimate
Estimated Value 45.5
Confidence Interval (2-Sided) 95%
41.2 to 49.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nesofilcon A
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear Mixed Model Analysis
Comments Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.
Method of Estimation Estimation Parameter LS Mean Estimate
Estimated Value 46.4
Confidence Interval (2-Sided) 95%
42.1 to 50.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.21
Estimation Comments [Not Specified]
Time Frame Throughout the entire duration of the study. Approximately 1 month per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Delefilcon A Nesofilcon A
Hide Arm/Group Description All subjects that wore the delefilcon A lens during either the first or second period of the study. All subjects that wore the nesofilcon A lens during either the first or second period of the study.
All-Cause Mortality
Delefilcon A Nesofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/78 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Delefilcon A Nesofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/78 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Delefilcon A Nesofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/78 (0.00%) 
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: Thomas Karkkainen, OD, MS, FAAO- Sr. Principal Research Optometrist
Organization: Johnson & Johnson Vision Care Inc.
Phone: 1-904-443-3402
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03322423     History of Changes
Other Study ID Numbers: CR-5860
First Submitted: September 28, 2017
First Posted: October 26, 2017
Results First Submitted: October 31, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019