Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Study Overview
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Brief Summary
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This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.

Official Title
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Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Conditions
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Myopia

Intervention / Treatment
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* Device: 1 Day Acuvue Moist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be enrolled in the parent protocol for at least one year. 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 this clinical protocol. Exclusion Criteria: Ocular or systemic allergies that may interfere with contact lens wear. Systemic disease or autoimmune disease or use of medication (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 Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study. Strabismus. 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, except for the parent trial Surgically altered eyes, ocular infection of any type, ocular inflammation. Anterior chamber angle grade 2 or narrower by Van Herrick method.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test lens C<br>Test lens C from previous study | Device: 1 Day Acuvue Moist<br>* Lenses will be worn in a daily wear modality<br>|
| Active Comparator: Test lens A<br>Test lens A from previous study | Device: 1 Day Acuvue Moist<br>* Lenses will 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 of the Eye | Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis. | Baseline and every 6 months post-baseline up to 18 months | 
| Spherical Equivalent Refractive Error | Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. | Baseline and every 6 months up to 18 months |