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.

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: G4 Multifocal soft contact lens with a 54% water content for presbyopia

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ra'anana, Israel
    • CLC
  • Ramat Gan, Israel
    • Bar Ilan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single arm; G4 Multifocal soft contact lens with a 54% water content for presbyopia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess visual acuity	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.	11-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess subjective degree of comfort while wearing the lenses	Participants will be asked to fill in a "Subjective Use Questionnaire" (appendix 2) .	11-12 months
SLIT LAMP EXAM	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.	11-12 months

Collaborators and Investigators

• Sponsor: Hanita Lenses

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): February 16, 2021
• Study Completion (Actual): February 16, 2021

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: G4Multi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No