Controlling Myopia Progression With Soft Contact Lenses

NCT ID: NCT01787760

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-01
• Study Completion Date: 2010-04-01

Brief Summary

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

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Soft Contact Lens B

Lenses will be worn in a daily disposable modality

Group Type: EXPERIMENTAL

Test Soft Contact Lens B

Intervention Type: DEVICE

Test lenses to be worn in daily wear modality

Test Soft Contact Lens C

Lenses will be worn in a daily disposable modality

Group Type: EXPERIMENTAL

Test Soft Contact Lens C

Intervention Type: DEVICE

Test lenses to be worn in a daily wear modality

Spectacle Lenses

Control spectacle lenses worn daily.

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: DEVICE

Control spectacle lenses to be worn in a daily wear modality

Interventions

Test Soft Contact Lens B

Test lenses to be worn in daily wear modality

Intervention Type: DEVICE

Test Soft Contact Lens C

Test lenses to be worn in a daily wear modality

Intervention Type: DEVICE

Active Comparator

Control spectacle lenses to be worn in a daily wear modality

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject must be between 8 and 12 years of age and of Asia origin.

2. The subject's 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. Less than 1.00D difference in spherical equivalent between the two eyes

5. The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes

6. The subject must have at least 8D of accommodation.

7. 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

8. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol

Exclusion Criteria

1. 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. antihistamines), which may interfere with contact lens wear.

3. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.

4. 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.

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 immunosuppressive disease (e.g. HIV).

8. Diabetes.

9. Anismetropia.

10. Astigmatism of greater than 1.00D in either eye.

11. Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.

12. Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye

13. Strabismus in either eye

14. Pupil or lid abnormality or infection in either eye

15. Central corneal scar and aphakia in either eye

16. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear

17. History of participation in clinical trials aimed to control myopia progression

18. Surgically altered eyes, ocular infection of any type, ocular inflammation

19. Subject has anterior chamber angle grade 2 or narrower

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Countries

Hong Kong

Other Identifiers

CR-1561AC

Identifier Type: -

Identifier Source: org_study_id