Novel Multifocal Soft Contact Lens Study

Ohio State University1 site in 1 country10 target enrollmentDecember 14, 2023

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Ohio State University
Enrollment: 10
Locations: 1
Primary Endpoint: Distance Visual Acuity
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 14, 2023

End Date

January 12, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ohio State University

Responsible Party

Principal Investigator

Jennifer Fogt

Ohio State University

Eligibility Criteria

Inclusion Criteria

•Ability to give informed consent
•Any racial or ethnic origin
•18 - 40 years of age
•Distance visual acuity with best corrected visual acuity of 20/25 with each eye
•Habitual soft contact lens wearer with myopia
•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

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