Status:
RECRUITING
To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.
Lead Sponsor:
Fitlens Ltd.
Collaborating Sponsors:
RSNESS
Conditions:
Myopia
Eligibility:
All Genders
8-12 years
Phase:
NA
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...
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 medica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05433792
Start Date
May 10 2022
End Date
January 1 2026
Last Update
June 28 2022
Active Locations (1)
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1
Wolfson Medical Center
Holon, Israel