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Myopia Progression After Ceasing Myopia Control Contact Lens Wear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829230
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : September 25, 2014
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Device: 1 Day Acuvue Moist Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arms and Interventions
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Arm Intervention/treatment
Experimental: Test lens C
Test lens C from previous study
 Device: 1 Day Acuvue Moist
Lenses will be worn in a daily wear modality
Active Comparator: Test lens A
Test lens A from previous study
 Device: 1 Day Acuvue Moist
Lenses will be worn in a daily wear modality


Outcome Measures
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Primary Outcome Measures :
  1. Axial Length of the Eye [ Time Frame: Baseline and every 6 months post-baseline up to 18 months ]
    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.

  2. Spherical Equivalent Refractive Error [ Time Frame: Baseline and every 6 months up to 18 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829230


Locations
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United States, Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
More Information
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01829230    
Other Study ID Numbers: CR-1561AF
First Posted: April 11, 2013    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: June 19, 2018
Last Verified: July 2015
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases