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Novel Multifocal Soft Contact Lens Study

The Ohio State University logo

The Ohio State University

Status

Completed

Conditions

Myopia

Treatments

Device: Investigational Contact Lens

Study type

Interventional

Funder types

Other

Identifiers

NCT06172881
2023W0119

Details and patient eligibility

About

A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.

Enrollment

10 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Ability to give informed consent
  2. Any gender
  3. Any racial or ethnic origin
  4. 18 - 40 years of age
  5. Distance visual acuity with best corrected visual acuity of 20/25 with each eye
  6. Habitual soft contact lens wearer with myopia
  7. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator).

Exclusion criteria

  1. Current or active ocular inflammation or infection as determined by the Investigator.
  2. Astigmatism > 0.75 D in either eye
  3. History of previous eye surgery
  4. Demonstration or history of corneal ectasia or keratoconus.
  5. Pregnant or lactating.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Distance Visual Acuity
Experimental group
Description:
Visual acuity will be measured while participant's wear study lenses.
Treatment:
Device: Investigational Contact Lens

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Jennifer Fogt, OS, MS; Emma Grant, BS

Data sourced from clinicaltrials.gov

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