Controlling Myopia Progression With Soft Contact Lenses

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

Official Title
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Controlling Myopia Progression With Soft Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Test Soft Contact Lens B
* Device: Test Soft Contact Lens C
* Device: Active Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Soft Contact Lens B<br>Lenses will be worn in a daily disposable modality | Device: Test Soft Contact Lens B<br>* Test lenses to be worn in daily wear modality<br>|
| Experimental: Test Soft Contact Lens C<br>Lenses will be worn in a daily disposable modality | Device: Test Soft Contact Lens C<br>* Test lenses to be worn in a daily wear modality<br>|
| Active Comparator: Spectacle Lenses<br>Control spectacle lenses worn daily. | Device: Active Comparator<br>* Control spectacle lenses to be worn in a daily wear modality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length (Axial Elongation) | 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. | Baseline and every 6 months post-baseline up to 3 years | 
| Spherical Equivalent Refraction | 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. | Baseline and every 6 months post-baseline up to 3 years |