Clinical trial NCT01787760: Controlling Myopia Progression With Soft Contact Lenses
Official title: Controlling Myopia Progression With Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 221
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Axial Length (Axial Elongation)
timeFrame: Baseline and every 6 months post-baseline up to 3 years
measure: Spherical Equivalent Refraction
timeFrame: Baseline and every 6 months post-baseline up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
References: