A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use

Hanita Lenses

Status: Completed

Conditions: Presbyopia

Treatments: Device: G4 Multifocal soft contact lens with a 54% water content for presbyopia

Study type: Interventional

Funder types: Industry

Identifiers

NCT04841941

G4Multi

Details and patient eligibility

About

The G4 Multi multifocal contact lens is a soft contact lens intended to correct far, intermediate, and near vision for individuals with presbyopia. The lens covers the cornea and part of the sclera. The lenses can be used for daily wear for up to 1 year.

Full description

Study Design:

A clinical performance study without a control group to compare the G4Multi contact lens to other approved soft contact lenses for presbyopia

Study Objectives:

1. To assess the multifocal vision in the various ranges of the HANITA G4 Multi.
2. To rate the comfort of the lenses in individuals with presbyopia

Study population:

Healthy men and women above the age of 18 diagnosed with presbyopia who have used contact lenses in the past

Recruitment :

A total of 30 subjects completing at least 1 month of participation.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presbyopia participants with healthy eyes who are not using any ocular medications, aged 18 years and over and who have used contact lenses in the past
2. Lens powers within the range available for the test lenses
3. Best spectacle-corrected visual acuity equal or greater than 20/25 (less than or equal to Log MAR 0.1)

Exclusion criteria

1. Anterior segment infection, inflammation, or abnormality
2. Any active anterior segment ocular disease that would contraindicate contact lens wear
3. The use of systemic or ocular medications that would contraindicate contact lens wear
4. History of herpetic keratitis
5. History of refractive surgery or irregular cornea
6. Slit lamp findings that are more serious than grade 1
7. Corneal vascularization greater than 1 mm of penetration
8. Pathologically dry eye;
9. Participation in a contact lens or contact lens care product clinical trial within the previous 30 days

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

single arm

Experimental group

Description:

G4 Multifocal soft contact lens with a 54% water content for presbyopia

Treatment:

Device: G4 Multifocal soft contact lens with a 54% water content for presbyopia