Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Completed · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT01829230

Run by

Johnson & Johnson Vision Care, Inc.

People needed

82

Starts

2010-03-01

Expected to finish

2011-10-01

Last updated by the study team

2018-06-19

Who can join

Age: 9 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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