N/A
N=137
Controlling Myopia Progression With Soft Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00762970 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Spherical Equivalent Refraction — -0.326; -0.460; -0.430; -0.898 diopter (D)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Lens 1 (Device); Test Lens 2 (Device); Control Lens (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spherical Equivalent Refraction |
-0.326; -0.460; -0.430; -0.898; -0.859; -0.905 | — |
| PRIMARY Axial Length (Axial Elongation) |
0.214; 0.198; 0.263; 0.401; 0.382; 0.458 | — |
Summary
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
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)
- 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
Data sourced from ClinicalTrials.gov (NCT00762970). 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.