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

Visioneering Technologies

Status: Enrolling

Conditions: Myopia

Treatments: Device: MiSight 1 Day contact lens; Device: NaturalVue Enhanced Multifocal 1 Day contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06475053

VTI-2405

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 9 to 30 years old

Volunteers: Accepts Healthy Volunteers

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 )

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

NaturalVue

Active Comparator group

Description:

NaturalVue Enhanced Multifocal 1 Day contact lens

Treatment:

Device: NaturalVue Enhanced Multifocal 1 Day contact lens

MiSight

Active Comparator group

Description:

MiSight 1 Day contact lens

Treatment:

Device: MiSight 1 Day contact lens