Controlling Myopia Progression With Soft Contact Lenses

N/ACompletedNCT00762970

Johnson & Johnson Vision Care, Inc.150 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Myopia

Interventions

Test Lens 1DEVICE

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

Test Lens 2DEVICE

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

Control LensDEVICE

Spectacle Lenses.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

The Tianjin Eye Hospital

Tianjin, China

Outcomes

Primary Outcomes

Spherical Equivalent Refraction

Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.

Time frame: Baseline and every 6 months post-baseline for 2 years

Axial Length (Axial Elongation)

Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.

Time frame: Baseline and every 6 months post-baseline for 2 years

Data from ClinicalTrials.gov

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