NCT04841941

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hanita Lenses · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	G4 Multifocal soft contact lens with a 54% water content for presbyopia	The participants must agree to wear lenses from a trial set with the fit assessed according to the "Fitting Guide". Prescription lenses will then be ordered from the manufacturer.

Timeline

• Start date: 2018-07-17
• Primary completion: 2021-02-16
• Completion: 2021-02-16
• First posted: 2021-04-12
• Last updated: 2021-04-12

Locations

2 sites across 1 country: Israel