Clinical trial NCT06475053: Visual Performance of Center Distance Daily Disposable Multifocal Lenses
Official title: Visual Performance of Center Distance Daily Disposable Multifocal Lenses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Contact lens
Multifocal
Lead sponsor: Visioneering Technologies, Inc
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
First posted: 2024-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a prospective, double-masked, crossover trial.
Primary purpose: OTHER

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.


Eligibility criteria: 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 )

Primary outcomes:
measure: Comparison of visual performance (high and low contrast acuity) between VTI NaturalVue Enhanced Multifocal and CooperVision MiSight.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: The Ohio State University College of Optometry
name: Marjean T Kulp, OD, MS
role: PRINCIPAL_INVESTIGATOR
References: