Controlling Myopia Progression With Soft Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: Control Lens; Device: Test Lens 1; Device: Test Lens 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762970

CR-1561AB

Details and patient eligibility

About

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.

Full description

The study will be a prospective, randomized, single blind, bilateral dispensing study

Enrollment: 150 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Myopic subjects between 8 and 12 years of age.
2. 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)
3. Astigmatism must be less than or equal to 1.00D
4. 1.00D or less difference in spherical equivalent between the two eyes
5. 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
6. The subject must have at least 8D of accommodation
7. The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT
8. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with 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. Anisometropia of greater than 1.00D
10. Astigmatism of greater than 1.00D in either eye
11. Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
12. Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye.
13. Strabismus in either eye
14. Pupil orr lid abnormality or infection in either eye
15. Central corneal scar in either eye
16. Aphakia in either eye
17. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
18. History of participation in prior clinical trials aimed to control myopia progression
19. Surgically altered eyes, ocular infection of any type, ocular inflammation
20. Subject has anterior chamber angle grade 2 or narrower

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Test Lens 1

Experimental group

Description:

Investigational soft contact lenses worn daily.

Treatment:

Device: Test Lens 1

Test Lens 2

Experimental group

Description:

Investigational soft contact lenses worn daily.

Treatment:

Device: Test Lens 2

Control lens

Active Comparator group

Description:

Spectacle lenses worn daily.

Treatment:

Device: Control Lens