Status:
COMPLETED
A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use
Lead Sponsor:
Hanita Lenses
Conditions:
Presbyopia
Eligibility:
All Genders
18+ years
Phase:
NA
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. T...
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 multif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04841941
Start Date
July 17 2018
End Date
February 16 2021
Last Update
April 12 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
CLC
Raanana, Israel
2
Bar Ilan
Ramat Gan, Israel