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

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: G4 Multifocal soft contact lens with a 54% water content for presbyopia

• Registration Number: NCT04841941
• Lead Sponsor: Hanita Lenses

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.

Study Timeline

• Study Start: 2018-07-17
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Study First Submitted: 2021-03-09
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	G4 Multifocal soft contact lens with a 54% water content for presbyopia	G4 Multifocal soft contact lens with a 54% water content for presbyopia

Primary Outcome Measures

Name	Time	Method
Assess visual acuity	11-12 months	Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be measured with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms.; Results will be recorded in a Log Mar scale.

Secondary Outcome Measures

Name	Time	Method
Assess subjective degree of comfort while wearing the lenses	11-12 months	Participants will be asked to fill in a "Subjective Use Questionnaire" (appendix 2) .
SLIT LAMP EXAM	11-12 months	The slit lamp exam will include the entire cornea, sclera and conjunctiva exclusion symptoms: See ISO 11980 Annex B (informative) Procedures for the evaluation of safety, physiological performance and effects on ocular tissues.

Trial Locations

Locations (2)

Bar Ilan; 🇮🇱 Ramat Gan, Israel

CLC; 🇮🇱 Ra'anana, Israel