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

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: NCT01829191
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : July 29, 2015
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

Condition or disease Intervention/treatment Phase
Myopia Device: Soft Contact Test Lens A Device: Soft Contact Test Lens C Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Controlling Myopia Progression With Soft Contact Lenses
Actual Study Start Date : April 1, 2008
Actual Primary Completion Date : May 1, 2010
Actual Study Completion Date : May 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Test Lens A
Test lenses will be worn in a daily wear modality
Device: Soft Contact Test Lens A
FDA-approved, non-marketed daily disposable soft contact lens, conventional design

Experimental: Test Lens C
Test lenses will be worn in a daily wear modality
Device: Soft Contact Test Lens C
Daily disposable soft contact lens with new optical design




Primary Outcome Measures :
  1. Spherical Equivalent Refractive Error [ Time Frame: Baseline and every 6 months post-baseline for 2 years ]
    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 :
  1. Axial Length [ Time Frame: Baseline and every 6 months for 2 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01829191


Locations
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United States, Massachusetts
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01829191    
Other Study ID Numbers: CR-1561AD
First Posted: April 11, 2013    Key Record Dates
Results First Posted: July 29, 2015
Last Update Posted: June 19, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases