Controlling Myopia Progression With Soft Contact Lenses

Myopia Clinical Trial

Official title:

Controlling Myopia Progression With Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787760
• Other study ID #: CR-1561AC
• Status: Completed
• Phase: N/A
• Start date: April 1, 2007
• Est. completion date: April 1, 2010

Study information

• Verified date: April 2018
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: April 1, 2010
• Est. primary completion date: April 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test Soft Contact Lens B
Test lenses to be worn in daily wear modality
• Test Soft Contact Lens C
Test lenses to be worn in a daily wear modality
• Active Comparator
Control spectacle lenses to be worn in a daily wear modality

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Length (Axial Elongation)	Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.	Baseline and every 6 months post-baseline up to 3 years
Primary	Spherical Equivalent Refraction	Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.	Baseline and every 6 months post-baseline up to 3 years