Controlling Myopia Progression With Soft Contact Lenses

NCT ID: NCT00762970

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-01
• Study Completion Date: 2010-02-01

Brief Summary

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

Detailed Description

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

Conditions

Myopia

Study Design

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

Study Groups

Test Lens 1

Investigational soft contact lenses worn daily.

Group Type: EXPERIMENTAL

Test Lens 1

Intervention Type: DEVICE

Investigational soft contact lens with asperic optical design to control myopia progression.

Test Lens 2

Investigational soft contact lenses worn daily.

Group Type: EXPERIMENTAL

Test Lens 2

Intervention Type: DEVICE

Investigational soft contact lens with asperic optical design to control myopia progression.

Control lens

Spectacle lenses worn daily.

Group Type: ACTIVE_COMPARATOR

Control Lens

Intervention Type: DEVICE

Spectacle Lenses.

Interventions

Test Lens 1

Investigational soft contact lens with asperic optical design to control myopia progression.

Intervention Type: DEVICE

Test Lens 2

Investigational soft contact lens with asperic optical design to control myopia progression.

Intervention Type: DEVICE

Control Lens

Spectacle Lenses.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

Principal Investigators

Xu Cheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Clinical Scientist

Locations

The Tianjin Eye Hospital

Tianjin, , China

Countries

China

Other Identifiers

CR-1561AB

Identifier Type: -

Identifier Source: org_study_id