Novel Multifocal Soft Contact Lens Study

Myopia Clinical Trial

Official title:

Novel Multifocal Soft Contact Lens Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06172881
• Other study ID #: 2023W0119
• Status: Completed
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: January 12, 2024

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Investigational Contact Lens
A soft contact lens that will be worn only at the study visit.

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Myoptechs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)