Novel Multifocal Soft Contact Lens Study

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Investigational Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distance Visual Acuity; Visual acuity will be measured while participant's wear study lenses.	Device: Investigational Contact Lens; A soft contact lens that will be worn only at the study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity	LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.	1 day (This is a single visit study)

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Myoptechs
• Investigators: Principal Investigator: Jennifer Fogt, OD, MS, The Ohio State University College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 12, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2023W0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No