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Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

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.
ClinicalTrials.gov Identifier: NCT03431441
Recruitment Status : Completed
First Posted : February 13, 2018
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Visual Acuity
Intervention Device: JJVC Marketed Contact Lens
Enrollment 26
Recruitment Details A total of 26 subjects were enrolled in the study. Of those enrolled, 24 subjects were assigned and administered. Of the total assigned subjects, 19 subjects completed the study, while 5 subjects were discontinued from the study.
Pre-assignment Details  
Arm/Group Title Test
Hide Arm/Group Description Subject that wore the etafilcon A lenses throughout the entire duration of the study.
Period Title: Overall Study
Started [1] 24
Completed [2] 19
Not Completed 5
Reason Not Completed
Withdrawal by Subject             2
Adverse Event             2
Dispensed Incorrect Replacement Lens             1
[1]
24
[2]
19
Arm/Group Title Test
Hide Arm/Group Description Subject that wore the etafilcon A lenses throughout the entire duration of the study.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 24 participants
28.6  (5.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
24
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
5
  20.8%
Not Hispanic or Latino
19
  79.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
1
   4.2%
Asian
2
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  16.7%
White
17
  70.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title LogMAR Objective Vision (High Illumination/High Contrast)
Hide Description Monocular high illuminance high contrast VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.
Time Frame 5 minutes after lens fitting
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one study article regardless of the randomization status.
Arm/Group Title Test
Hide Arm/Group Description:
Subject that wore the etafilcon A lenses throughout the entire duration of the study.
Overall Number of Participants Analyzed 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
46
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.105  (0.0546)
Time Frame Throughout the entire duration of the study, approximately 10 to 14 days per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test
Hide Arm/Group Description Subject that wore the etafilcon A lenses throughout the entire duration of the study.
All-Cause Mortality
Test
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Test
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test
Affected / at Risk (%)
Total   0/24 (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: Meredith Bishop OD, MS, FAAO
Organization: Johnson & Johnson Vision Care
Phone: 904-443-1396
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03431441     History of Changes
Other Study ID Numbers: CR-6180
First Submitted: February 6, 2018
First Posted: February 13, 2018
Results First Submitted: February 7, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019