Clinical trial NCT00762970: 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: 2008-09-30
Enrollment: 150
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.

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

Eligibility 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

Primary outcomes:
measure: Spherical Equivalent Refraction
timeFrame: Baseline and every 6 months post-baseline for 2 years
measure: Axial Length (Axial Elongation)
timeFrame: Baseline and every 6 months post-baseline for 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The Tianjin Eye Hospital
Study officials:
affiliation: Principal Clinical Scientist
name: Xu Cheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: