To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Myolens CN (Central-Near) soft contact lens
MiSight® soft contact lens
Sponsored by
About this trial
This is an interventional prevention trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Wolfson Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Myolens CN
Myolens CF
MiSight®
Arm Description
Subjects' will be allocated to Myolens CN study arm in a 1:1:1 ratio.
Subjects' will be allocated to Myolens CF study arm in a 1:1:1 ratio.
Subjects' will be allocated to MiSight® study arm in a 1:1:1 ratio.
Outcomes
Primary Outcome Measures
Axial length change 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.
Spherical equivalent change from baseline visit to 12 months visit.
Secondary Outcome Measures
BCVA change from baseline visit to 12 months visit.
BCVA change 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.
Spherical equivalent change from baseline visit to 24 months visit.
Spherical equivalent change 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.
Axial length change from baseline visit to 36 months visit.
Axial length change 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.
BCVA change from baseline visit to 36 months visit.
BCVA change from baseline visit to 36 months visit.
Axial length change in CN arm
Axial length change in CN arm
Spherical equivalent change in CN arm
Spherical equivalent change in CN arm
BCVA change in CN arm
BCVA change in CN arm
Axial length change in CF arm
Axial length change in CF arm
Spherical equivalent change in CF arm
Spherical equivalent change in CF arm
BCVA change in CF arm
BCVA change in CF arm
Full Information
NCT ID
NCT05433792
First Posted
June 7, 2022
Last Updated
June 27, 2022
Sponsor
Fitlens Ltd.
Collaborators
RSNESS
1. Study Identification
Unique Protocol Identification Number
NCT05433792
Brief Title
To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fitlens Ltd.
Collaborators
RSNESS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myolens CN
Arm Type
Experimental
Arm Description
Subjects' will be allocated to Myolens CN study arm in a 1:1:1 ratio.
Arm Title
Myolens CF
Arm Type
Experimental
Arm Description
Subjects' will be allocated to Myolens CF study arm in a 1:1:1 ratio.
Arm Title
MiSight®
Arm Type
Active Comparator
Arm Description
Subjects' will be allocated to MiSight® study arm in a 1:1:1 ratio.
Intervention Type
Device
Intervention Name(s)
Myolens CN (Central-Near) soft contact lens
Other Intervention Name(s)
Myolens CF (Central-Far) soft contact lens
Intervention Description
Personal fitting of the Myolens-CN/CF.
Intervention Type
Device
Intervention Name(s)
MiSight® soft contact lens
Intervention Description
Control arm device, FDA approved (P180035), and CE marked soft lenses for the management of Myopia in children aged 8-12.
Primary Outcome Measure Information:
Title
Axial length change from baseline visit to 12 months visit.
Description
Axial length change from baseline visit to 12 months visit.
Time Frame
from baseline visit to 12 months visit
Title
Spherical equivalent change from baseline visit to 12 months visit.
Description
Spherical equivalent change from baseline visit to 12 months visit.
Time Frame
from baseline visit to 12 months visit
Secondary Outcome Measure Information:
Title
BCVA change from baseline visit to 12 months visit.
Description
BCVA change from baseline visit to 12 months visit.
Time Frame
from baseline visit to 12 months visit
Title
Axial length change from baseline visit to 24 months visit.
Description
Axial length change from baseline visit to 24 months visit.
Time Frame
from baseline visit to 24 months visit
Title
Spherical equivalent change from baseline visit to 24 months visit.
Description
Spherical equivalent change from baseline visit to 24 months visit.
Time Frame
from baseline visit to 24 months visit
Title
BCVA change from baseline visit to 24 months visit.
Description
BCVA change from baseline visit to 24 months visit.
Time Frame
from baseline visit to 24 months visit
Title
Axial length change from baseline visit to 36 months visit.
Description
Axial length change from baseline visit to 36 months visit.
Time Frame
from baseline visit to 36 months visit
Title
Spherical equivalent change from baseline visit to 36 months visit.
Description
Spherical equivalent change from baseline visit to 36 months visit.
Time Frame
from baseline visit to 36 months visit
Title
BCVA change from baseline visit to 36 months visit.
Description
BCVA change from baseline visit to 36 months visit.
Time Frame
from baseline visit to 36 months visit
Title
Axial length change in CN arm
Description
Axial length change in CN arm
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
Spherical equivalent change in CN arm
Description
Spherical equivalent change in CN arm
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
BCVA change in CN arm
Description
BCVA change in CN arm
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
Axial length change in CF arm
Description
Axial length change in CF arm
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
Spherical equivalent change in CF arm
Description
Spherical equivalent change in CF arm
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
BCVA change in CF arm
Description
BCVA change in CF arm
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Other Pre-specified Outcome Measures:
Title
Rate of device related Adverse Events.
Description
Rate of device related Adverse Events.
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
Exploratory Endpoint.
Description
Comparing CN and CF in change in axial length, spherical equivalate and BCVA.
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
Exploratory Endpoint.
Description
Comparing CN and CF in change in spherical equivalate
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
Title
Exploratory Endpoint.
Description
Comparing CN and CF in change in BCVA.
Time Frame
Up to 36 months after last patient recruitment) = last subject enrolled study completion).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avner Avrahami
Phone
(0)54-2281158
Ext
+972
Email
avner.avrahami@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cheli Gonnen
Phone
(0)54-6448097
Ext
+972
Email
chelig@rs-ness.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitza Cohen, MD
Organizational Affiliation
Bnei- Zion MC. Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oriel Shpirer, MD
Organizational Affiliation
Wolfson MC. Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shiri Shulman, MD
Organizational Affiliation
Assuta- Hashalom MC. Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José M González Méijome, MD
Organizational Affiliation
University of Minho- Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oriel Spierer, MD
Phone
+972547277119
Email
OrielS@wmc.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.
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