NCT05495971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

August 8, 2022

Results QC Date

June 13, 2024

Last Update Submit

December 12, 2024

Conditions

Presbyopia

Keywords

soft contact lens

Outcome Measures

Primary Outcomes (1)

  • LogMAR Visual Acuity

    High contrast/high illumination distant (6M) logMAR vision

    4 hours

Study Arms (1)

Presbyopia

EXPERIMENTAL

Subject's baseline vision will be compared with vision wearing treatment product

Device: NaturalVue Multifocal

Interventions

NaturalVue MultifocalDEVICE

EDOF

Presbyopia

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suitable and able to wear contact lenses
  • Normal best corrected vision (20/25 or better)
  • Need reading add +2.00 or stronger

You may not qualify if:

  • Pre-existing ocular condition that would contraindicating lens wear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VTI

Alpharetta, Georgia, 30009, United States

Location

Related Publications (1)

  • Tuan KA, Benoit DP, O'Connor B. Evaluation of the Functional Visual Range of a Catenary Curve-Based, Extended Depth-of-Focus Contact Lens for Presbyopia. Clin Ophthalmol. 2024 Jul 19;18:2113-2123. doi: 10.2147/OPTH.S468699. eCollection 2024.

    PMID: 39055378DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Dr. Douglas P. Benoit
Organization
Visioneering Technologies, Inc.
dbenoit@vtivision.com
6035459507

Study Officials

  • Douglas P. Benoit, OD

    Visioneering Technologies, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Subjects will serve as their own control using objective baseline data.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

September 6, 2022

Primary Completion

May 12, 2023

Study Completion

May 12, 2023

Last Updated

December 16, 2024

Results First Posted

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)