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Vistakon Investigational Lens Worn as a Single Use Daily Wear

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ClinicalTrials.gov Identifier: NCT01031004
Recruitment Status : Completed
First Posted : December 14, 2009
Results First Posted : March 17, 2011
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: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: narafilcon B
Device: etafilcon A
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description single use, daily wear contact lens contact lens worn as single use, daily wear
Period Title: Overall Study
Started 25 25
Completed 24 24
Not Completed 1 1
Reason Not Completed
Protocol Violation             0             1
Lost to Follow-up             1             0
Arm/Group Title Narafilcon B Etafilcon A Total
Hide Arm/Group Description single use, daily wear contact lens contact lens worn as single use, daily wear Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
29.2  (8.19) 29.2  (8.08) 29.2  (8.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
17
  68.0%
18
  72.0%
35
  70.0%
Male
8
  32.0%
7
  28.0%
15
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Slit Lamp Findings - Corneal Edema
Hide Description Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
2.Primary Outcome
Title Corneal Edema at Month 1
Hide Description Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
3.Primary Outcome
Title Slit Lamp Findings - Corneal Neovascularization
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
4.Primary Outcome
Title Slit Lamp Findings - Corneal Neovascularization
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
5.Primary Outcome
Title Slit Lamp Findings - Corneal Staining
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
6.Primary Outcome
Title Slit Lamp Findings - Corneal Staining
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
1 0
7.Primary Outcome
Title Slit Lamp Findings - Injection
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
8.Primary Outcome
Title Slit Lamp Findings - Injection
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
9.Primary Outcome
Title Slit Lamp Findings - Tarsal Abnormalities
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
10.Primary Outcome
Title Slit Lamp Findings - Tarsal Abnormalities
Hide Description Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
11.Primary Outcome
Title Slit Lamp Findings - Infiltrates
Hide Description Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
12.Primary Outcome
Title Slit Lamp Findings - Infiltrates
Hide Description Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
13.Primary Outcome
Title Subject Reported Symptoms
Hide Description Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
15 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narafilcon B, Etafilcon A
Comments The hypothesis is that narafilcon B is not statistically different from etafilcon A.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0466
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
14.Primary Outcome
Title Subject Reported Symptoms
Hide Description Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
14 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narafilcon B, Etafilcon A
Comments The hypothesis is that narafilcon B is not statistically different from etafilcon A.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1069
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
15.Primary Outcome
Title Visual Acuity (VA)
Hide Description Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.
Time Frame after 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narafilcon B, Etafilcon A
Comments The hypothesis is that narafilcon B is not statistically different from etafilcon A.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4605
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
16.Primary Outcome
Title Visual Acuity (VA)
Hide Description Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.
Time Frame after 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 48
Measure Type: Number
Unit of Measure: eyes
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narafilcon B, Etafilcon A
Comments The hypothesis is that narafilcon B is not statistically different from etafilcon A.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5774
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
17.Primary Outcome
Title Average Wear Time
Hide Description [Not Specified]
Time Frame after 1 week of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: hours per day
13.9  (1.91) 13.7  (2.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narafilcon B, Etafilcon A
Comments The hypothesis is that narafilcon B will not be statistically different from etafilcon A.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6403
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Primary Outcome
Title Average Wear Time
Hide Description [Not Specified]
Time Frame after 1 month of lens wear
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all participants that completed the study per protocol.
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description:
single use, daily wear contact lens
contact lens worn as single use, daily wear
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: hours per day
13.6  (2.33) 13.8  (2.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narafilcon B, Etafilcon A
Comments The hypothesis is that narafilcon B is not statistically different from etafilcon A.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7217
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Narafilcon B Etafilcon A
Hide Arm/Group Description single use, daily wear contact lens contact lens worn as single use, daily wear
All-Cause Mortality
Narafilcon B Etafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Narafilcon B Etafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Narafilcon B Etafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (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.
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
Results Point of Contact
Name/Title: John Buch/Principal Research Optometrist
Organization: Vistakon
Phone: 904-443-1707
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01031004     History of Changes
Other Study ID Numbers: CR-1655
First Submitted: November 18, 2009
First Posted: December 14, 2009
Results First Submitted: February 22, 2011
Results First Posted: March 17, 2011
Last Update Posted: June 19, 2018