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 Overview
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Brief Summary
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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
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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.

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

Conditions
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Presbyopia

Intervention / Treatment
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* Device: G4 Multifocal soft contact lens with a 54% water content for presbyopia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>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<br>* 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.<br>|

What is the study measuring?
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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 |