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Trial record 36 of 11721 for:    Contact

Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

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: NCT02394925
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : May 15, 2017
Last Update Posted : June 19, 2018
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 Vision Correction
Intervention Device: Multifocal Test Contact lens
Enrollment 113
Recruitment Details  
Pre-assignment Details A total of 113 enrolled into this study. Of the enrolled, 5 subjects did not meet the eligibility criteria and 108 subjects were dispensed the study lens. Of the dispensed subjects 79 completed the study while 29 subjects were discontinued.
Arm/Group Title Etafilcon -PVP (Multi-focal)
Hide Arm/Group Description All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
Period Title: Overall Study
Started 108
Completed 79
Not Completed 29
Reason Not Completed
Adverse Event             1
Lens Discomfort             3
Lens handling difficulities             5
Lost to Follow-up             9
Protocol Violation             5
No longer meet eligibility criteria             1
Unsatisfactory Visual Response             5
Arm/Group Title Dispensed Subjects
Hide Arm/Group Description All subjects in that were dispensed the study lens.
Overall Number of Baseline Participants 108
Hide Baseline Analysis Population Description
All subjects that were dispensed the study lens.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
49.9  (6.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
61
  56.5%
Male
47
  43.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
31
  28.7%
White
73
  67.6%
More than one race
0
   0.0%
Unknown or Not Reported
3
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants
United States 46
United Kingdom 62
1.Primary Outcome
Title Proportion of Successful Contact Lens Wearers
Hide Description Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers.
Time Frame 2 months post wear
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Etafilcon -PVP (Multi-focal)
Hide Arm/Group Description:
All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: Proportion of Subjects
0.71
Time Frame Throughout the duration of the study. Approximately 2-months per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etafilcon -PVP (Multi-focal)
Hide Arm/Group Description All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
All-Cause Mortality
Etafilcon -PVP (Multi-focal)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etafilcon -PVP (Multi-focal)
Affected / at Risk (%)
Total   0/108 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etafilcon -PVP (Multi-focal)
Affected / at Risk (%)
Total   0/108 (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
Layout table for Results Point of Contact information
Name/Title: Thomas R. Karkkainen, OD, MS, FAAO Sr. Principal Research Optometrist
Organization: Johnson & Johnson Vision Care Inc.
Phone: 904 443-3402
EMail: TKarkkai@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02394925     History of Changes
Other Study ID Numbers: CR-5672
First Submitted: March 16, 2015
First Posted: March 20, 2015
Results First Submitted: April 6, 2017
Results First Posted: May 15, 2017
Last Update Posted: June 19, 2018