Controlling Myopia Progression With Soft Contact Lenses

N/ACompletedNCT01787760

Johnson & Johnson Vision Care, Inc.221 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

221

Conditions

Myopia

Interventions

Test Soft Contact Lens BDEVICE

Test lenses to be worn in daily wear modality

Test Soft Contact Lens CDEVICE

Test lenses to be worn in a daily wear modality

Active ComparatorDEVICE

Control spectacle lenses to be worn in a daily wear modality

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Outcomes

Primary Outcomes

Axial Length (Axial Elongation)

Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.

Time frame: Baseline and every 6 months post-baseline up to 3 years

Spherical Equivalent Refraction

Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.

Time frame: Baseline and every 6 months post-baseline up to 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.