Novel Multifocal Soft Contact Lens Study

Ohio State University10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

Investigational Contact LensDEVICE

A soft contact lens that will be worn only at the study visit.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Ohio State University College of Optometry

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 day (This is a single visit study)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.