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Controlling Myopia Progression With Soft Contact Lenses

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status

Completed

Conditions

Myopia

Treatments

Device: Test Soft Contact Lens B
Device: Test Soft Contact Lens C
Device: Active Comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01787760
CR-1561AC

Details and patient eligibility

About

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

Enrollment

221 patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. The subject must be between 8 and 12 years of age and of Asia origin.
  2. The subject's 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. Less than 1.00D difference in spherical equivalent between the two eyes
  5. The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes
  6. The subject must have at least 8D of accommodation.
  7. 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
  8. The subject must appear able and willing to adhere to the instructions set forth in the 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 medication (e.g. antihistamines), which may interfere with contact lens wear.
  3. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
  4. 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.
  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 immunosuppressive disease (e.g. HIV).
  8. Diabetes.
  9. Anismetropia.
  10. Astigmatism of greater than 1.00D in either eye.
  11. Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
  12. Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
  13. Strabismus in either eye
  14. Pupil or lid abnormality or infection in either eye
  15. Central corneal scar and aphakia in either eye
  16. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear
  17. History of participation in clinical trials aimed to control myopia progression
  18. Surgically altered eyes, ocular infection of any type, ocular inflammation
  19. Subject has anterior chamber angle grade 2 or narrower

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

221 participants in 3 patient groups

Test Soft Contact Lens B
Experimental group
Description:
Lenses will be worn in a daily disposable modality
Treatment:
Device: Test Soft Contact Lens B
Test Soft Contact Lens C
Experimental group
Description:
Lenses will be worn in a daily disposable modality
Treatment:
Device: Test Soft Contact Lens C
Spectacle Lenses
Active Comparator group
Description:
Control spectacle lenses worn daily.
Treatment:
Device: Active Comparator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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