To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.

NCT ID: NCT05433792

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2026-01-31

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)

1. Obtaining inform consent.

2. Obtaining subject's relevant medical history and concomitant therapy - concurrent active medical conditions with emphasis on ocular and systemic diseases.

3. Performance of ophthalmic examination (slit lamp), IOP, BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation, Cover test, fundus photography and corneal topography.

4. Confirmatiom of subject's eligiblity

5. Subject's randomization to either of the study arms

6. Personal fitting of the Myolens-CN/CF or MiSight as per randomization

Week 1 Day 1 (±3 days)

1. Performance of ophthalmic examination (slit lamp), BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation.

2. Subject will be instructed regarding the use and handling of the lens both written and verbally.

3. AE and concomitant therapy monitoring

Treatment period (36 months)

1. The lenses will be worn by the subject every day, for a maximum of 14 hours per day.

2. For the subjects allocated to either CN or CF arm, lenses will be replaced every 3 months.

3. At M36 visit lenses will be removed.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Myolens CN

Subjects' will be allocated to Myolens CN study arm in a 1:1:1 ratio.

Group Type: EXPERIMENTAL

Myolens CN (Central-Near) soft contact lens

Intervention Type: DEVICE

Personal fitting of the Myolens-CN/CF.

Myolens CF

Subjects' will be allocated to Myolens CF study arm in a 1:1:1 ratio.

Group Type: EXPERIMENTAL

Myolens CN (Central-Near) soft contact lens

Intervention Type: DEVICE

Personal fitting of the Myolens-CN/CF.

MiSight®

Subjects' will be allocated to MiSight® study arm in a 1:1:1 ratio.

Group Type: ACTIVE_COMPARATOR

MiSight® soft contact lens

Intervention Type: DEVICE

Control arm device, FDA approved (P180035), and CE marked soft lenses for the management of Myopia in children aged 8-12.

Interventions

Myolens CN (Central-Near) soft contact lens

Personal fitting of the Myolens-CN/CF.

Intervention Type: DEVICE

MiSight® soft contact lens

Control arm device, FDA approved (P180035), and CE marked soft lenses for the management of Myopia in children aged 8-12.

Intervention Type: DEVICE

Other Intervention Names

Myolens CF (Central-Far) soft contact lens

Eligibility Criteria

Inclusion Criteria

1. Be between 8 and 12 years of age inclusive at baseline examination.

2. The participant has been given a detailed, clear explanation concerning the study aspects and procedures.

3. The participant's parents or legal guardian have been given a clear explanation, then read, understood, and signed the informed consent form.

4. Willingness to adhere to protocol, agreement to maintain the visit schedule.

5. 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.

6. 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.

7. Subject with normal eyes who is not using any ocular medications.

8. Possess wearable and visually functional eyeglasses.

9. Be in good general health, based on his/her and parent's/guardian's knowledge.

10. 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).

11. The manifest cylinder is less than or equal to 0,75D.

12. Meet the following refractive criteria determined by cycloplegic autorefraction at baseline (per eye):

1. Spherical equivalent refractive error: between -0.75 and -4.00 D inclusive.

2. Astigmatism: ≤-0.75 D

3. Anisometropia: <1.00 D

Exclusion Criteria

1. Subject is currently or within 30 days before this study has been an active participant in another clinical study involving an investigational treatment.

2. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, or any other myopia control treatment.

3. Birth earlier than 30 week or <1500 g (3.3 lb) at birth.

4. Regular use of ocular medications, artificial tears, or wetting agents.

5. Current use of systemic medications, which may affect contact lens wear, tear film production, pupil size, accommodation, or refractive state.

6. A known allergy to any of the Myolens components.

7. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or other recurrent ocular infections.

8. Strabismus by cover test at distance or near wearing distance correction.

9. 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.

10. Keratoconus or an irregular cornea (assessed by corneas topography)

11. Contraindications for contact lens wear including giant papillary conjunctivitis of grade 2 or worse and allergic or seasonal conjunctivitis (assessed by slit lamp exam)

12. 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.

13. Slit lamp findings that are more serious than grade 1 according to the Efron Grading Scale.

14. Corneal vascularization greater than 1 mm of penetration

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RSNESS

UNKNOWN

Sponsor Role: collaborator

Fitlens Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nitza Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Bnei- Zion MC. Israel

Oriel Shpirer, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson MC. Israel

Shiri Shulman, MD

Role: PRINCIPAL_INVESTIGATOR

Assuta- Hashalom MC. Israel

José M González Méijome, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minho- Portugal

Locations

Wolfson Medical Center

Holon, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Avner Avrahami

Role: CONTACT

avner.avrahami@live.com

(0)54-2281158 ext. +972

Cheli Gonnen

Role: CONTACT

chelig@rs-ness.com

(0)54-6448097 ext. +972

Facility Contacts

Oriel Spierer, MD

Role: primary

OrielS@wmc.gov.il

+972547277119

Other Identifiers

FL-CN/CF-01

Identifier Type: -

Identifier Source: org_study_id