Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contact Lens Insertion and Removal in a Senior Subject Demographic

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: NCT03597178
Recruitment Status : Completed
First Posted : July 24, 2018
Results First Posted : August 12, 2019
Last Update Posted : August 27, 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: Device Feasibility
Condition Visual Acuity
Intervention Device: senofilcon A
Enrollment 16
Recruitment Details A total of 16 subjects were enrolled into this study. Of those enrolled, 2 failed to meet all eligibility criteria. Of 14 dispensed subjects all completed the study.
Pre-assignment Details  
Arm/Group Title Senofilcon A
Hide Arm/Group Description Subjects that wore senofilcon A during the entire duration of the study
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title All Dispensed Subjects
Hide Arm/Group Description All subjects dispensed a study lens.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
65.3  (2.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
5
  35.7%
Male
9
  64.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 14 participants
14
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
 100.0%
1.Primary Outcome
Title Overall Success Rate of Insertion and Removal of a Contact Lens
Hide Description The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.
Time Frame Lens insertion and Removal, up to 2-Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who successfully ompleted all study visits and did not substanially deviate from the protocol as deterined by the trial cohort review committee prior to database lock.
Arm/Group Title Senofilcon A
Hide Arm/Group Description:
Subjects that inserted and removed the senofilcon A lens.
Overall Number of Participants Analyzed 14
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
28
Measure Type: Number
Unit of Measure: Percentage of eyes
85.7
Time Frame Throughout the entire duration of the study. Approximately 1 day per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Senofilcon A
Hide Arm/Group Description Subjects that wore the senofilcon A during any in this study.
All-Cause Mortality
Senofilcon A
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Senofilcon A
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Senofilcon A
Affected / at Risk (%)
Total   0/14 (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: Brian Pall OD, MS, FAAO- Director of Clinical Sciences
Organization: Johnson & Johnson
Phone: 9044431290
EMail: BPALL@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03597178     History of Changes
Other Study ID Numbers: CR-6289
First Submitted: July 13, 2018
First Posted: July 24, 2018
Results First Submitted: July 1, 2019
Results First Posted: August 12, 2019
Last Update Posted: August 27, 2019