Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

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: Soft Contact Test Lens A
* Device: Soft Contact Test Lens C


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. At least one of the subject's parents or legal guardian must read and understand English or Chinese. The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: <1.50D in each eye. The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes). The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: < or equal to 1.00D in each eye. The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction. The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes. The subject's parent or legal guardian must read and sign the STAEMENT 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 this 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 medications (e.g. antihistamine), which may 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. 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 by cycloplegic refraction. Astigmatism of greater than 1.00D in either eye by cycloplegic refraction. Eye injury or surgery within eight weeks immediately prior to enrollment for this study. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks. Strabismus in either eye. Pupil or 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. An anterior chamber angle grade 2 or narrower by the Van Herrick method

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Lens A<br>Test lenses will be worn in a daily wear modality | Device: Soft Contact Test Lens A<br>* FDA-approved, non-marketed daily disposable soft contact lens, conventional design<br>|
| Experimental: Test Lens C<br>Test lenses will be worn in a daily wear modality | Device: Soft Contact Test Lens C<br>* Daily disposable soft contact lens with new optical design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical Equivalent Refractive Error | Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia. | Baseline and every 6 months post-baseline for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length | Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis. | Baseline and every 6 months for 2 years |