Evaluating a new soft lens for myopia control in children

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.

This study is testing if special soft contact lenses can help slow down worsening eyesight in children aged 8 to 12 who have myopia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 8 Years to 12 Years
• Sex: All
• Sponsor: Fitlens Ltd. (Industry-sponsored)
• Locations: 1 site (Holon)
• Trial ID: NCT05433792 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of specially designed Myolens soft contact lenses in slowing the progression of myopia in children aged 8 to 12. Participants will undergo a screening process, including ophthalmic examinations and medical history assessments, before being randomly assigned to wear either Myolens CN or MiSight lenses for a maximum of 14 hours daily over a 36-month treatment period. Follow-up visits will monitor their eye health and lens effectiveness through various assessments. The goal is to determine if these lenses can significantly reduce myopia progression compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are children aged 8 to 12 years with normal eyes who are willing to adhere to the study protocol and wear contact lenses daily.

Not a fit: Patients with existing ocular conditions or those not willing to comply with the lens-wearing schedule may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective option for controlling myopia progression in children, potentially reducing the risk of serious eye conditions later in life.

How similar studies have performed: Previous studies have shown that other myopia control methods, such as multifocal lenses, can slow progression, suggesting potential for success with this novel lens approach.

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

Where this trial is running

Holon

• Wolfson Medical Center — Holon, Israel (Recruiting)

Study contacts

• Principal investigator: Nitza Cohen, MD — Bnei- Zion MC. Israel
• Study coordinator: Avner Avrahami

Conditions Myopia