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Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1 Day Acuvue Moist
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

9 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The subject must be enrolled in the parent protocol for at least one year.
  2. 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.
  3. 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 that may interfere with contact lens wear.
  2. Systemic disease or autoimmune disease or use of medication (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. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
  10. Strabismus.
  11. Pupil or lid abnormality or infection in either eye
  12. Central corneal scar in either eye
  13. Aphakia in either eye
  14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
  15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
  16. Surgically altered eyes, ocular infection of any type, ocular inflammation.
  17. Anterior chamber angle grade 2 or narrower by Van Herrick method.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test lens C

Test lens A

Arm Description

Test lens C from previous study

Test lens A from previous study

Outcomes

Primary Outcome Measures

Axial Length of the Eye
Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.
Spherical Equivalent Refractive Error
Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.

Secondary Outcome Measures

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
NCT01829230
Brief Title
Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Official Title
Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (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 is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.

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
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test lens C
Arm Type
Experimental
Arm Description
Test lens C from previous study
Arm Title
Test lens A
Arm Type
Active Comparator
Arm Description
Test lens A from previous study
Intervention Type
Device
Intervention Name(s)
1 Day Acuvue Moist
Intervention Description
Lenses will be worn in a daily wear modality
Primary Outcome Measure Information:
Title
Axial Length of the Eye
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 at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.
Time Frame
Baseline and every 6 months post-baseline up to 18 months
Title
Spherical Equivalent Refractive Error
Description
Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.
Time Frame
Baseline and every 6 months up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject must be enrolled in the parent protocol for at least one year. 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 this clinical protocol. Exclusion Criteria: Ocular or systemic allergies that may interfere with contact lens wear. Systemic disease or autoimmune disease or use of medication (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 Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study. Strabismus. 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, except for the parent trial Surgically altered eyes, ocular infection of any type, ocular inflammation. Anterior chamber angle grade 2 or narrower by Van Herrick method.
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Myopia Progression After Ceasing Myopia Control Contact Lens Wear

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