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Controlling Myopia Progression With Soft Contact Lenses

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: NCT00762970
Recruitment Status : Completed
First Posted : September 30, 2008
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: Test Lens 1 Device: Test Lens 2 Device: Control Lens Not Applicable

Detailed Description:
The study will be a prospective, randomized, single blind, bilateral dispensing study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Actual Study Start Date : April 1, 2007
Actual Primary Completion Date : February 1, 2010
Actual Study Completion Date : February 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Test Lens 1
Investigational soft contact lenses worn daily.
Device: Test Lens 1
Investigational soft contact lens with asperic optical design to control myopia progression.

Experimental: Test Lens 2
Investigational soft contact lenses worn daily.
Device: Test Lens 2
Investigational soft contact lens with asperic optical design to control myopia progression.

Active Comparator: Control lens
Spectacle lenses worn daily.
Device: Control Lens
Spectacle Lenses.




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

  2. Axial Length (Axial Elongation) [ Time Frame: Baseline and every 6 months post-baseline for 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00762970


Locations
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China
The Tianjin Eye Hospital
Tianjin, China, 300020
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Investigators
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Principal Investigator: Xu Cheng, MD, PhD Principal Clinical Scientist
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00762970    
Other Study ID Numbers: CR-1561AB
First Posted: September 30, 2008    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