Controlling Myopia Progression With Soft Contact Lenses

Not Applicable

Completed

Interventions: Device: Active Comparator
Device: Test Soft Contact Lens C
Device: Test Soft Contact Lens B

Brief Summary: This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.

Recruitment & Eligibility

Inclusion Criteria

The subject must be between 8 and 12 years of age and of Asia origin.
The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
Astigmatism must be less than or equal to 1.00D
Less than 1.00D difference in spherical equivalent between the two eyes
The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes
The subject must have at least 8D of accommodation.
The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form
The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol

Exclusion Criteria

Ocular or systemic allergies or diseases that may interfere with contact lens wear
Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
Diabetes.
Anismetropia.
Astigmatism of greater than 1.00D in either eye.
Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
Strabismus in either eye
Pupil or lid abnormality or infection in either eye
Central corneal scar and aphakia in either eye
Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear
History of participation in clinical trials aimed to control myopia progression
Surgically altered eyes, ocular infection of any type, ocular inflammation
Subject has anterior chamber angle grade 2 or narrower

Arm && Interventions

Group	Intervention	Description
Spectacle Lenses	Active Comparator	Control spectacle lenses worn daily.
Test Soft Contact Lens C	Test Soft Contact Lens C	Lenses will be worn in a daily disposable modality
Test Soft Contact Lens B	Test Soft Contact Lens B	Lenses will be worn in a daily disposable modality

Primary Outcome Measures

Name	Time	Method
Axial Length (Axial Elongation)	Baseline and every 6 months post-baseline up to 3 years	Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.
Spherical Equivalent Refraction	Baseline and every 6 months post-baseline up to 3 years	Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.

Secondary Outcome Measures

Name	Time	Method

Locations (1): The Hong Kong Polytechnic University
🇭🇰
Hung Hom, Kowloon, Hong Kong
The Hong Kong Polytechnic University
🇭🇰Hung Hom, Kowloon, Hong Kong