Controlling Myopia Progression With Soft Contact Lenses

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Test Lens 1	Test Lens 1	Investigational soft contact lenses worn daily.
Test Lens 2	Test Lens 2	Investigational soft contact lenses worn daily.
Control lens	Control Lens	Spectacle lenses worn daily.

Primary Outcome Measures

Name	Time	Method
Spherical Equivalent Refraction	Baseline and every 6 months post-baseline for 2 years	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.
Axial Length (Axial Elongation)	Baseline and every 6 months post-baseline for 2 years	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.

Secondary Outcome Measures