Controlling Myopia Progression With Soft Contact Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762970
• Other study ID #: CR-1561AB
• Status: Completed
• Phase: N/A
• Start date: April 1, 2007
• Est. completion date: February 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 1, 2010
• Est. primary completion date: February 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test Lens 1
Investigational soft contact lens with asperic optical design to control myopia progression.
• Test Lens 2
Investigational soft contact lens with asperic optical design to control myopia progression.
• Control Lens
Spectacle Lenses.

Locations

Country	Name	City	State
China	The Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical Equivalent Refraction	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.	Baseline and every 6 months post-baseline for 2 years
Primary	Axial Length (Axial Elongation)	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.	Baseline and every 6 months post-baseline for 2 years