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

NCT ID: NCT04841941

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2021-02-16

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

single arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanita Lenses

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CLC

Raanana, , Israel

Bar Ilan

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

G4Multi

Identifier Type: -

Identifier Source: org_study_id