Controlling Myopia Progression With Soft Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 150
- 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.
Detailed Description
The study will be a prospective, randomized, single blind, bilateral dispensing study
Investigators
Eligibility Criteria
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)
- •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.
Outcomes
Primary Outcomes
Spherical Equivalent Refraction
Time Frame: 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)
Time Frame: 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.