N/A
N=152
Controlling Myopia Progression With Soft Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01787760 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Axial Length (Axial Elongation) — 0.158; 0.144; 0.121; 0.242 millimeter (mm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Soft Contact Lens B (Device); Test Soft Contact Lens C (Device); Active Comparator (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Axial Length (Axial Elongation) |
0.158; 0.144; 0.121; 0.242; 0.236; 0.222 | — |
| PRIMARY Spherical Equivalent Refraction |
-0.238; -0.327; -0.230; -0.417; -0.456; -0.429 | — |
Summary
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
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).
- Diabetes.
- 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.
- Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
- Strabismus in either eye
- Pupil or lid abnormality or infection in either eye
- Central corneal scar and 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 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
Data sourced from ClinicalTrials.gov (NCT01787760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.