Visual Performance of Center Distance Daily Disposable Multifocal Lenses (ViPCD3)

The purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between Visioneering Technologies, Inc. NaturalVue Multifocal and CooperVivion MiSight.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: NaturalVue Enhanced Multifocal 1 Day contact lens; Device: MiSight 1 Day contact lens

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must satisfy the following conditions for inclusion in the trial:

  • Be between 9 and 30 years of age
  • Sign written Informed Consent/Assent.
  • Spherical Equivalent glasses prescription: -0.50 to -7.00 diopters (D), Astigmatism: ≤ -0.75D, Anisometropia: ≤ 1.00D
  • 20/20 vision in each eye
  • Existing contact lens wearer
  • An eye exam in last 9 months, normal stereoacuity on prior chart (or test if not available)
  • No known ocular disease - anterior or posterior (posterior determined by history/chart)
  • Have an acceptable or optimal fit with test lenses and be willing to wear these lenses as directed for the duration of the study.
  • On examination, have ocular findings considered to be within normal limits.
  • Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria:

• Any of the following will exclude a participant from this trial:

  • Current hard lens wearers
  • Using eye medication contraindicating lens wear such as daily use of artificial tears.
  • Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  • History of corneal refractive surgery
  • Currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Allergy or sensitivity to any product used in this trial.
  • Pre-existing ocular condition that would contraindicate lens wear.
  • Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by wearing contact lenses.
  • Lazy eye (Strabismus or amblyopia)
  • Pupil size < 3.00 mm in either eye in dim light (measured at approximately 10 cd/m2 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NaturalVue; NaturalVue Enhanced Multifocal 1 Day contact lens	Device: NaturalVue Enhanced Multifocal 1 Day contact lens; Daily disposable multifocal contact lens
Active Comparator: MiSight; MiSight 1 Day contact lens	Device: MiSight 1 Day contact lens; Daily disposable dual-focus contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of visual performance (high and low contrast acuity) between VTI NaturalVue Enhanced Multifocal and CooperVision MiSight.	log MAR vision scale	2 months

Collaborators and Investigators

• Sponsor: Visioneering Technologies, Inc
• Collaborators: Ohio State University
• Investigators: Principal Investigator: Marjean T Kulp, OD, MS, The Ohio State University College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Contact lens; Multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Equipment and Supplies; Optical Devices; Lenses; Contact Lenses
• Other Study ID Numbers: VTI-2405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes