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

NCT04841941 | Completed

• 1 other identifier: G4Multi
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assess subjective degree of comfort while wearing the lenses

  11-12 months

• SLIT LAMP EXAM

  11-12 months

Study Arms (1)

single arm

EXPERIMENTAL

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

Interventions

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

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (2)

CLC

Raanana, Israel

Location

Bar Ilan

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: April 12, 2021
• Study Start: July 17, 2018
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

IL (2)