Novel Multifocal Soft Contact Lens Study

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)

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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