PresbyopiaNCT04841941
A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use
A study testing G4 Multifocal soft contact lens with a 54% water content for presbyopia in people with Presbyopia, run by Hanita Lenses at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- G4 Multifocal soft contact lens with a 54% water content for presbyopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesIsrael
- Study dates
- 17 Jul 2018to 16 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Presbyopia
- Being tested
- G4 Multifocal soft contact lens with a 54% water content for presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G4 Multifocal soft contact lens with a 54% water content for presbyopiaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | G4 Multifocal soft contact lens with a 54% water content for presbyopia Receives: Device: G4 Multifocal soft contact lens with a 54% water content for presbyopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11-12 months
Secondary outcomes (2)
Assess subjective degree of comfort while wearing the lenses
Participants will be asked to fill in a "Subjective Use Questionnaire" (appendix 2) .
Measured: 11-12 months
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.
Measured: 11-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start17 Jul 2018
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841941
- Sponsor's protocol ID
- G4Multi
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04841941
- Acronym / sponsor ID
- G4Multi
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: G4 Multifocal soft contact lens with a 54% water content for presbyopiaG4 Multifocal soft contact lens with a 54% water content for presbyopia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G4 Multifocal soft contact lens with a 54% water content for presbyopiaThe 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. | Device | single arm |
Primary outcome
Assess visual acuity
Time frame: 11-12 months
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.
2 secondary outcomes
Assess subjective degree of comfort while wearing the lenses
Time frame: 11-12 months
SLIT LAMP EXAM
Time frame: 11-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G4 Multifocal soft contact lens with a 54% water content for presbyopia in people with Presbyopia, run by Hanita Lenses at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess visual acuity (time frame: 11-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021; AzTrials last refreshed its copy on 29 Oct 2026.