Controlling Myopia Progression With Soft Contact Lenses

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

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