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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841941
• Other study ID #: G4Multi
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: February 16, 2021

Study information

• Verified date: April 2021
• Source: Hanita Lenses
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
Israel	CLC	Ra'anana
Israel	Bar Ilan	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Hanita Lenses

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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