Controlling Myopia Progression With Soft Contact Lenses

NCT01787760 | Completed Results DMC

• 1 other identifier: CR-1561AC
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Study Arms (3)

Test Soft Contact Lens B

EXPERIMENTAL

Lenses will be worn in a daily disposable modality

Device: Test Soft Contact Lens B

Test Soft Contact Lens C

EXPERIMENTAL

Lenses will be worn in a daily disposable modality

Device: Test Soft Contact Lens C

Spectacle Lenses

ACTIVE COMPARATOR

Control spectacle lenses worn daily.

Device: Active Comparator

Interventions

Test Soft Contact Lens B DEVICE

Test lenses to be worn in daily wear modality

Test Soft Contact Lens B

Test Soft Contact Lens C DEVICE

Test lenses to be worn in a daily wear modality

Test Soft Contact Lens C

Active Comparator DEVICE

Control spectacle lenses to be worn in a daily wear modality

Spectacle Lenses

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The subject must be between 8 and 12 years of age and of Asia origin.
• 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)
• Astigmatism must be less than or equal to 1.00D
• Less than 1.00D difference in spherical equivalent between the two eyes
• 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
• The subject must have at least 8D of accommodation.
• 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
• The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol

You may not qualify if:

• Ocular or systemic allergies or diseases that may interfere with contact lens wear
• Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
• 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.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
• Diabetes.
• Anismetropia.
• Astigmatism of greater than 1.00D in either eye.
• Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
• Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
• Strabismus in either eye
• Pupil or lid abnormality or infection in either eye
• Central corneal scar and aphakia in either eye

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: XU CHENG, PRINCIPAL CLINICAL SCIENTIST
• Organization: Vistakon, USA

xcheng6@its.jnj.com

1 904 443-1245

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 11, 2013
• Study Start: April 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: July 29, 2015

Record last verified: 2018-04

Locations

HK (1)