Back to resultsA Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
G4 Multifocal soft contact lens with a 54% water content for presbyopia
Sponsored by
About this trial
This is an interventional supportive care trial for Presbyopia
Eligibility Criteria
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
Sites / Locations
- CLC
- Bar Ilan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
G4 Multifocal soft contact lens with a 54% water content for presbyopia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assess subjective degree of comfort while wearing the lenses
Participants will be asked to fill in a "Subjective Use Questionnaire" (appendix 2) .
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04841941
Brief 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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
February 16, 2021 (Actual)
Study Completion Date
February 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanita Lenses
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
G4 Multifocal soft contact lens with a 54% water content for presbyopia
Intervention Type
Device
Intervention Name(s)
G4 Multifocal soft contact lens with a 54% water content for presbyopia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess visual acuity
Description
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.
Time Frame
11-12 months
Secondary Outcome Measure Information:
Title
Assess subjective degree of comfort while wearing the lenses
Description
Participants will be asked to fill in a "Subjective Use Questionnaire" (appendix 2) .
Time Frame
11-12 months
Title
SLIT LAMP EXAM
Description
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.
Time Frame
11-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CLC
City
Ra'anana
Country
Israel
Facility Name
Bar Ilan
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use
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