Controlling Myopia Progression With Soft Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 221
- Locations
- 1
- Primary Endpoint
- Spherical Equivalent Refraction
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject must be between 8 and 12 years of age and of Asia origin.
- •The subject's 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
- •Less than 1.00D difference in spherical equivalent between the two eyes
- •The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes
- •The subject must have at least 8D of accommodation.
- •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 the 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 medication (e.g. antihistamines), which may interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might 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.
- •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 immunosuppressive disease (e.g. HIV).
- •Anismetropia.
- •Astigmatism of greater than 1.00D in either eye.
- •Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
Outcomes
Primary Outcomes
Spherical Equivalent Refraction
Time Frame: Baseline and every 6 months post-baseline up to 3 years
Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.
Axial Length (Axial Elongation)
Time Frame: Baseline and every 6 months post-baseline up to 3 years
Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.