Visual Performance of Center Distance Daily Disposable Multifocal Lenses

NCT06475053 | Active Not Recruiting FDA Device

• 1 other identifier: VTI-2405
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Keywords

Contact lens; Multifocal

Outcome Measures

Primary Outcomes (1)

• Comparison of visual performance (high and low contrast acuity) between VTI NaturalVue Enhanced Multifocal and CooperVision MiSight.

  log MAR vision scale

  2 months

Study Arms (2)

NaturalVue

ACTIVE COMPARATOR

NaturalVue Enhanced Multifocal 1 Day contact lens

Device: NaturalVue Enhanced Multifocal 1 Day contact lens

MiSight

ACTIVE COMPARATOR

MiSight 1 Day contact lens

Device: MiSight 1 Day contact lens

Interventions

NaturalVue Enhanced Multifocal 1 Day contact lens DEVICE

Daily disposable multifocal contact lens

NaturalVue

MiSight 1 Day contact lens DEVICE

Daily disposable dual-focus contact lens

MiSight

Eligibility Criteria

• Age: 9 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Visioneering Technologies, Inc: lead
• Ohio State University: collaborator

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Marjean T Kulp, OD, MS

  The Ohio State University College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the examiner tasked with obtaining study outcome data will be masked to the design or brand of lenses. An unmasked examiner will be available to address any issues of lens wear or other adverse events.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a prospective, double-masked, crossover trial.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 26, 2024
• Study Start: July 31, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)