MyopiaNCT05433792
To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.
A study testing Myolens CN (Central-Near) soft contact lens and MiSight® soft contact lens in people with Myopia, run by Fitlens Ltd. at 1 site in Israel.
Trial summary
Myopia is a common disorder, affecting approximately one-third of the US population and over 90% of the population in some East Asian countries. High amounts of myopia are associated with an increased risk of sight-threatening problems, such as retinal detachment, choroidal degeneration, cataracts, and glaucoma. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Myolens CN (Central-Near) soft contact lens and MiSight® soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- 10 May 2022to Jan 2026
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be between 8 and 12 years of age inclusive at baseline examination.
- The participant has been given a detailed, clear explanation concerning the study aspects and procedures.
- The participant's parents or legal guardian have been given a clear explanation, then read, understood, and signed the informed consent form.
- Willingness to adhere to protocol, agreement to maintain the visit schedule.
- Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
- Agreement to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 3-year study.
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- Subject with normal eyes who is not using any ocular medications.
- Possess wearable and visually functional eyeglasses.
- Be in good general health, based on his/her and parent's/guardian's knowledge.
- Best-corrected visual acuity by manifest refraction of +0.10 log MAR (20/25 or 6/7.5) or better in each eye. (Lens power required limited to up to minus 10).
- The manifest cylinder is less than or equal to 0,75D.
- Meet the following refractive criteria determined by cycloplegic autorefraction at baseline (per eye):
- Spherical equivalent refractive error: between -0.75 and -4.00 D inclusive.
- Astigmatism: ≤-0.75 D
- Anisometropia: <1.00 D
Who cannot join
- Subject is currently or within 30 days before this study has been an active participant in another clinical study involving an investigational treatment.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, or any other myopia control treatment.
- Birth earlier than 30 week or <1500 g (3.3 lb) at birth.
- Regular use of ocular medications, artificial tears, or wetting agents.
- Current use of systemic medications, which may affect contact lens wear, tear film production, pupil size, accommodation, or refractive state.
- A known allergy to any of the Myolens components.
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- A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or other recurrent ocular infections.
- Strabismus by cover test at distance or near wearing distance correction.
- History of any of the following: ocular or systemic diseases, including those that could influence refractive development, anterior segment infection, inflammation or abnormality, any active anterior segment ocular disease that would contraindicate contact lens wear; history of herpetic keratitis; history of refractive surgery or irregular cornea (except when the contact lenses under investigation are indicated for irregular cornea, keratoconus or refractive surgery); a pathologically dry eye.
- Keratoconus or an irregular cornea (assessed by corneas topography)
- Contraindications for contact lens wear including giant papillary conjunctivitis of grade 2 or worse and allergic or seasonal conjunctivitis (assessed by slit lamp exam)
- Subject seems to exhibit poor personal hygiene (that in the investigator's opinion might prevent safe contact lens wear) or the investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
- Slit lamp findings that are more serious than grade 1 according to the Efron Grading Scale.
- Corneal vascularization greater than 1 mm of penetration
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson Medical Center
Holon
Oriel Spierer, MD, +972547277119, OrielS@wmc.gov.il
About this study
Official title: An Open Label, 3 Arms, Multicenter, Randomized . To Evaluate the Effectiveness Fitlens Soft Central Near and Central Far Contact Lens, Compared With MiSight for the Control of Progressive Juvenile Onset Myopia in Children Ages 8-12.
Myopia is a common disorder, affecting approximately one-third of the US population and over 90% of the population in some East Asian countries. High amounts of myopia are associated with an increased risk of sight-threatening problems, such as retinal detachment, choroidal degeneration, cataracts, and glaucoma. Slowing the progression of myopia could potentially benefit millions of children. To date, few strategies used for myopia control have proven to be effective. Currently, there are four categories of myopia control treatments: atropine eye drops, multifocal contact lenses, multifocal eyeglasses, and orthokeratology (ortho-k). None of these modalities are US Food and Drug Administration-approved to slow myopia progression, they have been shown to slow the progression by approximately 50% with few risks. Both orthokeratology and soft bifocal contact lenses have shown to slow myopia progression by slightly less than 50% in most studies.
The Myolens progressive front soft contact lens is designed to slow down myopia progression in children, The Myolens lens is an aspheric design with a spherical back surface that provides clear vision, with a uniform round edge for excellent fit and optimum comfort.
Read more
The Myolens-CN is designed with a central for the near optics, while the Myolens-CF with a central for the distance optics, which progressively changes to far area and within a defined optical zone area while considering the movement up-down of the lens on the cornea.
The thought behind the design is that the center of the lens will not provide a full optical correction.
In the suggested study, both Myolens modalities CN and CF will be investigated in compare to the current approved treatment - MiSight.
Read the detailed description
Study Procedures:
Screening period (up to 3 weeks prior to enrollment)
- Obtaining inform consent.
- Obtaining subject's relevant medical history and concomitant therapy - concurrent active medical conditions with emphasis on ocular and systemic diseases.
- Performance of ophthalmic examination (slit lamp), IOP, BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation, Cover test, fundus photography and corneal topography.
- Confirmatiom of subject's eligiblity
- Subject's randomization to either of the study arms
- Personal fitting of the Myolens-CN/CF or MiSight as per randomization
Week 1 Day 1 (±3 days)
- Performance of ophthalmic examination (slit lamp), BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation.
- Subject will be instructed regarding the use and handling of the lens both written and verbally.
- AE and concomitant therapy monitoring
Treatment period (36 months)
- The lenses will be worn by the subject every day, for a maximum of 14 hours per day.
- For the subjects allocated to either CN or CF arm, lenses will be replaced every 3 months.
- At M36 visit lenses will be removed.
- Each follow up visit will include: ophthalmic examination (slit lamp), BCVA test , axial length measurement, refractive assessment and spherical equivalence calculation, subject diary review, AE monitoring and changes in concomitant medications.
Follow up period (4 weeks) End of study (EOS) visit will be conducted 4 weeks after EOT. Completion of the study will be considered as the completion of visit 36M which will the EOT visit for the subject and 4 weeks follow up. In case of early termination, EOS will be conducted upon time of termination (UNS). EOS visit procedures are equal to 36M visit procedures.
- Conditions
- Myopia
- Being tested
- Myolens CN (Central-Near) soft contact lens, MiSight® soft contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myolens CN (Central-Near) soft contact lensDevice
Also called Myolens CF (Central-Far) soft contact lens
Personal fitting of the Myolens-CN/CF.
MiSight® soft contact lensDevice
Control arm device, FDA approved (P180035), and CE marked soft lenses for the management of Myopia in children aged 8-12.
| Study group | Role | What they receive |
|---|---|---|
| Myolens CN | Experimental | Subjects' will be allocated to Myolens CN study arm in a 1:1:1 ratio. Receives: Device: Myolens CN (Central-Near) soft contact lens |
| Myolens CF | Experimental | Subjects' will be allocated to Myolens CF study arm in a 1:1:1 ratio. Receives: Device: Myolens CN (Central-Near) soft contact lens |
| MiSight® | Active comparator | Subjects' will be allocated to MiSight® study arm in a 1:1:1 ratio. Receives: Device: MiSight® soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length change from baseline visit to 12 months visit.
Axial length change from baseline visit to 12 months visit.
Measured: from baseline visit to 12 months visit
Spherical equivalent change from baseline visit to 12 months visit.
Spherical equivalent change from baseline visit to 12 months visit.
Measured: from baseline visit to 12 months visit
Secondary outcomes (13)
BCVA change from baseline visit to 12 months visit.
BCVA change from baseline visit to 12 months visit.
Measured: from baseline visit to 12 months visit
Axial length change from baseline visit to 24 months visit.
Axial length change from baseline visit to 24 months visit.
Measured: from baseline visit to 24 months visit
Spherical equivalent change from baseline visit to 24 months visit.
Spherical equivalent change from baseline visit to 24 months visit.
Measured: from baseline visit to 24 months visit
BCVA change from baseline visit to 24 months visit.
BCVA change from baseline visit to 24 months visit.
Measured: from baseline visit to 24 months visit
Axial length change from baseline visit to 36 months visit.
Axial length change from baseline visit to 36 months visit.
Measured: from baseline visit to 36 months visit
Spherical equivalent change from baseline visit to 36 months visit.
Spherical equivalent change from baseline visit to 36 months visit.
Measured: from baseline visit to 36 months visit
BCVA change from baseline visit to 36 months visit.
BCVA change from baseline visit to 36 months visit.
Measured: from baseline visit to 36 months visit
Axial length change in CN arm
Axial length change in CN arm
Measured: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Spherical equivalent change in CN arm
Spherical equivalent change in CN arm
Measured: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
BCVA change in CN arm
BCVA change in CN arm
Measured: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Axial length change in CF arm
Axial length change in CF arm
Measured: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Spherical equivalent change in CF arm
Spherical equivalent change in CF arm
Measured: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
BCVA change in CF arm
BCVA change in CF arm
Measured: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start10 May 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open label, 3 arms, Multicenter, randomized study to evaluate the effectiveness of new specially designed Fitlens soft central near and central far contact lens, Myolens CN/CF Compared with MiSight® for the control of progressive juvenile onset Myopia in children ages 8-12. with no prior contact lens experience. Subjects will be allocated to either of the study arms - CN / CF or MiSight in a 1:1:1 ratio. The randomization for each arm will be done regardless the Myopia categories.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fitlens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RSNESS
- Responsible party
- Sponsor
- Investigators
- Nitza Cohen, MD, Principal investigator, Bnei- Zion MC. IsraelOriel Shpirer, MD, Principal investigator, Wolfson MC. IsraelShiri Shulman, MD, Principal investigator, Assuta- Hashalom MC. IsraelJosé M González Méijome, MD, Principal investigator, University of Minho- Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433792
- Sponsor's protocol ID
- FL-CN/CF-01
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, 3 Arms, Multicenter, Randomized . To Evaluate the Effectiveness Fitlens Soft Central Near and Central Far Contact Lens, Compared With MiSight for the Control of Progressive Juvenile Onset Myopia in Children Ages 8-12.
- ClinicalTrials.gov ID
- NCT05433792
- Acronym / sponsor ID
- FL-CN/CF-01
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fitlens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- RSNESS
- Study start
- 10 May 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 27 Jun 2022 (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.
Myopia is a common disorder, affecting approximately one-third of the US population and over 90% of the population in some East Asian countries. High amounts of myopia are associated with an increased risk of sight-threatening problems, such as retinal detachment, choroidal degeneration, cataracts, and glaucoma. Slowing the progression of myopia could potentially benefit millions of children. To date, few strategies used for myopia control have proven to be effective. Currently, there are four categories of myopia control treatments: atropine eye drops, multifocal contact lenses, multifocal eyeglasses, and orthokeratology (ortho-k). None of these modalities are US Food and Drug Administration-approved to slow myopia progression, they have been shown to slow the progression by approximately 50% with few risks. Both orthokeratology and soft bifocal contact lenses have shown to slow myopia progression by slightly less than 50% in most studies.
The Myolens progressive front soft contact lens is designed to slow down myopia progression in children, The Myolens lens is an aspheric design with a spherical back surface that provides clear vision, with a uniform round edge for excellent fit and optimum comfort.
The Myolens-CN is designed with a central for the near optics, while the Myolens-CF with a central for the distance optics, which progressively changes to far area and within a defined optical zone area while considering the movement up-down of the lens on the cornea.
The thought behind the design is that the center of the lens will not provide a full optical correction.
In the suggested study, both Myolens modalities CN and CF will be investigated in compare to the current approved treatment - MiSight.
Detailed description
Study Procedures:
Screening period (up to 3 weeks prior to enrollment)
- Obtaining inform consent.
- Obtaining subject's relevant medical history and concomitant therapy - concurrent active medical conditions with emphasis on ocular and systemic diseases.
- Performance of ophthalmic examination (slit lamp), IOP, BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation, Cover test, fundus photography and corneal topography.
- Confirmatiom of subject's eligiblity
- Subject's randomization to either of the study arms
- Personal fitting of the Myolens-CN/CF or MiSight as per randomization
Week 1 Day 1 (±3 days)
- Performance of ophthalmic examination (slit lamp), BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation.
- Subject will be instructed regarding the use and handling of the lens both written and verbally.
- AE and concomitant therapy monitoring
Treatment period (36 months)
- The lenses will be worn by the subject every day, for a maximum of 14 hours per day.
- For the subjects allocated to either CN or CF arm, lenses will be replaced every 3 months.
- At M36 visit lenses will be removed.
- Each follow up visit will include: ophthalmic examination (slit lamp), BCVA test , axial length measurement, refractive assessment and spherical equivalence calculation, subject diary review, AE monitoring and changes in concomitant medications.
Follow up period (4 weeks) End of study (EOS) visit will be conducted 4 weeks after EOT. Completion of the study will be considered as the completion of visit 36M which will the EOT visit for the subject and 4 weeks follow up. In case of early termination, EOS will be conducted upon time of termination (UNS). EOS visit procedures are equal to 36M visit procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open label, 3 arms, Multicenter, randomized study to evaluate the effectiveness of new specially designed Fitlens soft central near and central far contact lens, Myolens CN/CF Compared with MiSight® for the control of progressive juvenile onset Myopia in children ages 8-12. with no prior contact lens experience. Subjects will be allocated to either of the study arms - CN / CF or MiSight in a 1:1:1 ratio. The randomization for each arm will be done regardless the Myopia categories.
| Arm | Type | Receives |
|---|---|---|
| Myolens CN | Experimental | Device: Myolens CN (Central-Near) soft contact lensSubjects' will be allocated to Myolens CN study arm in a 1:1:1 ratio. |
| Myolens CF | Experimental | Device: Myolens CN (Central-Near) soft contact lensSubjects' will be allocated to Myolens CF study arm in a 1:1:1 ratio. |
| MiSight® | Active comparator | Device: MiSight® soft contact lensSubjects' will be allocated to MiSight® study arm in a 1:1:1 ratio. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Be between 8 and 12 years of age inclusive at baseline examination.
- The participant has been given a detailed, clear explanation concerning the study aspects and procedures.
- The participant's parents or legal guardian have been given a clear explanation, then read, understood, and signed the informed consent form.
- Willingness to adhere to protocol, agreement to maintain the visit schedule.
- Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
Key exclusion criteria (14 listed)
- Subject is currently or within 30 days before this study has been an active participant in another clinical study involving an investigational treatment.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, or any other myopia control treatment.
- Birth earlier than 30 week or <1500 g (3.3 lb) at birth.
- Regular use of ocular medications, artificial tears, or wetting agents.
- Current use of systemic medications, which may affect contact lens wear, tear film production, pupil size, accommodation, or refractive state.
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 |
|---|---|---|
| Myolens CN (Central-Near) soft contact lensAlso: Myolens CF (Central-Far) soft contact lensPersonal fitting of the Myolens-CN/CF. | Device | Myolens CF, Myolens CN |
| MiSight® soft contact lensControl arm device, FDA approved (P180035), and CE marked soft lenses for the management of Myopia in children aged 8-12. | Device | MiSight® |
Primary outcome
Axial length change from baseline visit to 12 months visit.
Time frame: from baseline visit to 12 months visit
Axial length change from baseline visit to 12 months visit.
Spherical equivalent change from baseline visit to 12 months visit.
Time frame: from baseline visit to 12 months visit
Spherical equivalent change from baseline visit to 12 months visit.
13 secondary outcomes
BCVA change from baseline visit to 12 months visit.
Time frame: from baseline visit to 12 months visit
Axial length change from baseline visit to 24 months visit.
Time frame: from baseline visit to 24 months visit
Spherical equivalent change from baseline visit to 24 months visit.
Time frame: from baseline visit to 24 months visit
BCVA change from baseline visit to 24 months visit.
Time frame: from baseline visit to 24 months visit
Axial length change from baseline visit to 36 months visit.
Time frame: from baseline visit to 36 months visit
Spherical equivalent change from baseline visit to 36 months visit.
Time frame: from baseline visit to 36 months visit
BCVA change from baseline visit to 36 months visit.
Time frame: from baseline visit to 36 months visit
Axial length change in CN arm
Time frame: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Spherical equivalent change in CN arm
Time frame: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
BCVA change in CN arm
Time frame: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Axial length change in CF arm
Time frame: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Spherical equivalent change in CF arm
Time frame: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
BCVA change in CF arm
Time frame: Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Nitza Cohen, MD principal investigator
Bnei- Zion MC. Israel
Oriel Shpirer, MD principal investigator
Wolfson MC. Israel
Shiri Shulman, MD principal investigator
Assuta- Hashalom MC. Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myolens CN (Central-Near) soft contact lens and MiSight® soft contact lens in people with Myopia, run by Fitlens Ltd. at 1 site 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 15 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avner Avrahami ((0)54-2281158 ext. +972, avner.avrahami@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length change from baseline visit to 12 months visit. (time frame: from baseline visit to 12 months visit). The study lists 2 primary outcomes in all. 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 28 Jun 2022.