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Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soft Contact Test Lens A
Soft Contact Test Lens C
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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The subject must be between 8 and 12 years of age.
  2. At least one of the subject's parents or legal guardian must read and understand English or Chinese.
  3. The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: <1.50D in each eye.
  4. The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes).
  5. The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: < or equal to 1.00D in each eye.
  6. The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction.
  7. The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes.
  8. The subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
  9. The subject must appear able and willing to adhere to the instructions set forth in this 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 medications (e.g. antihistamine), which may interfere with contact 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 by cycloplegic refraction.
  10. Astigmatism of greater than 1.00D in either eye by cycloplegic refraction.
  11. Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
  12. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks.
  13. Strabismus in either eye.
  14. Pupil or 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. An anterior chamber angle grade 2 or narrower by the Van Herrick method

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Test Lens A

Test Lens C

Arm Description

Test lenses will be worn in a daily wear modality

Test lenses will be worn in a daily wear modality

Outcomes

Primary Outcome Measures

Spherical Equivalent Refractive Error
Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.

Secondary Outcome Measures

Axial Length
Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.

Full Information

First Posted
April 8, 2013
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01829191
Brief Title
Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)
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, 2008 (Actual)
Primary Completion Date
May 1, 2010 (Actual)
Study Completion Date
May 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

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Lens A
Arm Type
Experimental
Arm Description
Test lenses will be worn in a daily wear modality
Arm Title
Test Lens C
Arm Type
Experimental
Arm Description
Test lenses will be worn in a daily wear modality
Intervention Type
Device
Intervention Name(s)
Soft Contact Test Lens A
Intervention Description
FDA-approved, non-marketed daily disposable soft contact lens, conventional design
Intervention Type
Device
Intervention Name(s)
Soft Contact Test Lens C
Intervention Description
Daily disposable soft contact lens with new optical design
Primary Outcome Measure Information:
Title
Spherical Equivalent Refractive Error
Description
Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.
Time Frame
Baseline and every 6 months post-baseline for 2 years
Secondary Outcome Measure Information:
Title
Axial Length
Description
Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.
Time Frame
Baseline and every 6 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject must be between 8 and 12 years of age. At least one of the subject's parents or legal guardian must read and understand English or Chinese. The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: <1.50D in each eye. The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes). The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: < or equal to 1.00D in each eye. The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction. The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes. The subject's parent or legal guardian must read and sign the STAEMENT 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 this 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 medications (e.g. antihistamine), which may 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. 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 by cycloplegic refraction. Astigmatism of greater than 1.00D in either eye by cycloplegic refraction. Eye injury or surgery within eight weeks immediately prior to enrollment for this study. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks. Strabismus in either eye. Pupil or 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. An anterior chamber angle grade 2 or narrower by the Van Herrick method
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30994197
Citation
Cheng X, Xu J, Brennan NA. Accommodation and its role in myopia progression and control with soft contact lenses. Ophthalmic Physiol Opt. 2019 May;39(3):162-171. doi: 10.1111/opo.12614.
Results Reference
derived

Learn more about this trial

Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

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