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.
NCT number | NCT04841941 |
Other study ID # | G4Multi |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 17, 2018 |
Est. completion date | February 16, 2021 |
Verified date | April 2021 |
Source | Hanita Lenses |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | CLC | Ra'anana | |
Israel | Bar Ilan | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Hanita Lenses |
Israel,
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 |
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