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Controlling Myopia Progression With Soft Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Test Soft Contact Lens B
Test Soft Contact Lens C
Active Comparator
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Test Soft Contact Lens B

Test Soft Contact Lens C

Spectacle Lenses

Arm Description

Lenses will be worn in a daily disposable modality

Lenses will be worn in a daily disposable modality

Control spectacle lenses worn daily.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2013
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01787760
Brief Title
Controlling Myopia Progression With Soft Contact Lenses
Official Title
Controlling Myopia Progression With Soft Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2007 (Actual)
Primary Completion Date
April 1, 2010 (Actual)
Study Completion Date
April 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Soft Contact Lens B
Arm Type
Experimental
Arm Description
Lenses will be worn in a daily disposable modality
Arm Title
Test Soft Contact Lens C
Arm Type
Experimental
Arm Description
Lenses will be worn in a daily disposable modality
Arm Title
Spectacle Lenses
Arm Type
Active Comparator
Arm Description
Control spectacle lenses worn daily.
Intervention Type
Device
Intervention Name(s)
Test Soft Contact Lens B
Intervention Description
Test lenses to be worn in daily wear modality
Intervention Type
Device
Intervention Name(s)
Test Soft Contact Lens C
Intervention Description
Test lenses to be worn in a daily wear modality
Intervention Type
Device
Intervention Name(s)
Active Comparator
Intervention Description
Control spectacle lenses to be worn in a daily wear modality
Primary Outcome Measure Information:
Title
Axial Length (Axial Elongation)
Description
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
Title
Spherical Equivalent Refraction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear History of participation in clinical trials aimed to control myopia progression Surgically altered eyes, ocular infection of any type, ocular inflammation Subject has anterior chamber angle grade 2 or narrower
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
State/Province
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

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Controlling Myopia Progression With Soft Contact Lenses

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