Back to resultsExtended Depth of Focus Contact Lenses for Presbyopia
Primary Purpose
Presbyopia
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NaturalVue Multifocal
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring soft contact lens
Eligibility Criteria
Inclusion Criteria:
- Suitable and able to wear contact lenses
- Normal best corrected vision (20/25 or better)
- Need reading add +2.00 or stronger
Exclusion Criteria:
- Pre-existing ocular condition that would contraindicating lens wear
Sites / Locations
- VTIRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Presbyopia
Arm Description
Subject's baseline vision will be compared with vision wearing treatment product
Outcomes
Primary Outcome Measures
LogMAR Visual Acuity
Vision at different viewing conditions
Secondary Outcome Measures
Full Information
NCT ID
NCT05495971
First Posted
August 8, 2022
Last Updated
October 3, 2022
Sponsor
Visioneering Technologies, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05495971
Brief Title
Extended Depth of Focus Contact Lenses for Presbyopia
Official Title
Extended Depth of Focus Contact Lenses for Presbyopia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visioneering Technologies, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
soft contact lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Subjects will serve as their own control using objective baseline data.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Presbyopia
Arm Type
Experimental
Arm Description
Subject's baseline vision will be compared with vision wearing treatment product
Intervention Type
Device
Intervention Name(s)
NaturalVue Multifocal
Intervention Description
EDOF
Primary Outcome Measure Information:
Title
LogMAR Visual Acuity
Description
Vision at different viewing conditions
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Suitable and able to wear contact lenses
Normal best corrected vision (20/25 or better)
Need reading add +2.00 or stronger
Exclusion Criteria:
Pre-existing ocular condition that would contraindicating lens wear
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doug Benoit, OD
Phone
603 545-9507
Email
dbenoit@vtivision.com
Facility Information:
Facility Name
VTI
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Benoit, OD
Email
dbenoit@vtivision.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extended Depth of Focus Contact Lenses for Presbyopia
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