Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: 1 Day Acuvue Moist

Study type: Interventional

Funder types: Industry

Identifiers

NCT01829230

CR-1561AF

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 9 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The subject must be enrolled in the parent protocol for at least one year.
2. 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.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

1. Ocular or systemic allergies that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
3. 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.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
10. Strabismus.
11. Pupil or lid abnormality or infection in either eye
12. Central corneal scar in either eye
13. Aphakia in either eye
14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
16. Surgically altered eyes, ocular infection of any type, ocular inflammation.
17. Anterior chamber angle grade 2 or narrower by Van Herrick method.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Test lens C

Experimental group

Description:

Test lens C from previous study

Treatment:

Device: 1 Day Acuvue Moist

Test lens A

Active Comparator group

Description:

Test lens A from previous study

Treatment:

Device: 1 Day Acuvue Moist