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Controlling Myopia Progression With Soft Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Test Lens 1
Test Lens 2
Control Lens
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. 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

Sites / Locations

  • The Tianjin Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Test Lens 1

Test Lens 2

Control lens

Arm Description

Investigational soft contact lenses worn daily.

Investigational soft contact lenses worn daily.

Spectacle lenses worn daily.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2008
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00762970
Brief 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
February 1, 2010 (Actual)
Study Completion Date
February 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
No

5. Study Description

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

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
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Lens 1
Arm Type
Experimental
Arm Description
Investigational soft contact lenses worn daily.
Arm Title
Test Lens 2
Arm Type
Experimental
Arm Description
Investigational soft contact lenses worn daily.
Arm Title
Control lens
Arm Type
Active Comparator
Arm Description
Spectacle lenses worn daily.
Intervention Type
Device
Intervention Name(s)
Test Lens 1
Intervention Description
Investigational soft contact lens with asperic optical design to control myopia progression.
Intervention Type
Device
Intervention Name(s)
Test Lens 2
Intervention Description
Investigational soft contact lens with asperic optical design to control myopia progression.
Intervention Type
Device
Intervention Name(s)
Control Lens
Intervention Description
Spectacle Lenses.
Primary Outcome Measure Information:
Title
Spherical Equivalent Refraction
Description
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
Title
Axial Length (Axial Elongation)
Description
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

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: Myopic subjects between 8 and 12 years of age. 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) Astigmatism must be less than or equal to 1.00D 1.00D or less difference in spherical equivalent between the two eyes 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 The subject must have at least 8D of accommodation The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with 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. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with 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 an immunosuppressive disease (e.g. HIV) Diabetes Anisometropia of greater than 1.00D Astigmatism of greater than 1.00D in either eye Eye injury or surgery within eight weeks immediately prior to enrollment for this study. Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye. Strabismus in either eye Pupil orr lid abnormality or infection in either eye Central corneal scar in either eye 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 prior 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Cheng, MD, PhD
Organizational Affiliation
Principal Clinical Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Tianjin Eye Hospital
City
Tianjin
ZIP/Postal Code
300020
Country
China

12. IPD Sharing Statement

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Controlling Myopia Progression With Soft Contact Lenses

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