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.

Detailed Description
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The study will be a prospective, randomized, single blind, bilateral dispensing study

Conditions
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Myopia

Intervention / Treatment
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* Device: Test Lens 1
* Device: Test Lens 2
* Device: Control Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myopic subjects between 8 and 12 years of age. The subject 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 1.00D or less difference in spherical equivalent between the two eyes The subject must have a best-corrected visual acuity of 0.8+2 (20/25+2) and spherical equivalent refraction visual acuity of 0.820/25) or better in both eyes The subject must have at least 8D of accommodation The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with 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. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with 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 an immunosuppressive disease (e.g. HIV) Diabetes Anisometropia of greater than 1.00D Astigmatism of greater than 1.00D in either eye Eye injury or surgery within eight weeks immediately prior to enrollment for this study. Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye. Strabismus in either eye Pupil orr lid abnormality or infection in either eye Central corneal scar in either eye 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 prior 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 Lens 1<br>Investigational soft contact lenses worn daily. | Device: Test Lens 1<br>* Investigational soft contact lens with asperic optical design to control myopia progression.<br>|
| Experimental: Test Lens 2<br>Investigational soft contact lenses worn daily. | Device: Test Lens 2<br>* Investigational soft contact lens with asperic optical design to control myopia progression.<br>|
| Active Comparator: Control lens<br>Spectacle lenses worn daily. | Device: Control Lens<br>* Spectacle Lenses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical Equivalent Refraction | Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia. | Baseline and every 6 months post-baseline for 2 years | 
| Axial Length (Axial Elongation) | Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up. | Baseline and every 6 months post-baseline for 2 years |