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

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:

• To assess the multifocal vision in the various ranges of the HANITA G4 Multi.
• 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.

Inclusion criteria

• 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
• Lens powers within the range available for the test lenses
• Best spectacle-corrected visual acuity equal or greater than 20/25 (less than or equal to Log MAR 0.1)

Exclusion criteria

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