Status:
COMPLETED
Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
9-13 years
Phase:
NA
Brief 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-app...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01829230
Start Date
March 1 2010
End Date
October 1 2011
Last Update
June 19 2018
Active Locations (1)
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1
Boston, Massachusetts, United States, 02215