N/A
N=82
Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01829230 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Axial Length of the Eye — 0.080; 0.073; 0.229; 0.231 millimeter (mm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1 Day Acuvue Moist (Device)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Axial Length of the Eye |
0.080; 0.073; 0.229; 0.231; 0.272; 0.255 | — |
| PRIMARY Spherical Equivalent Refractive Error |
-0.015; -0.155; -0.342; -0.471; -0.444; -0.569 | — |
Summary
This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.
Eligibility Criteria
Inclusion Criteria
- The subject must be enrolled in the parent protocol for at least one year.
- 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 this clinical protocol.
Exclusion Criteria
- Ocular or systemic allergies that may interfere with contact lens wear.
- Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may 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.
- 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
- Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
- Strabismus.
- Pupil or 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, except for the parent trial
- Surgically altered eyes, ocular infection of any type, ocular inflammation.
- Anterior chamber angle grade 2 or narrower by Van Herrick method.
Data sourced from ClinicalTrials.gov (NCT01829230). 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.