Controlling Myopia Progression With Soft Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Test Lens 1; Device: Test Lens 2; Device: Control Lens

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300020
    • The Tianjin Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Lens 1; Investigational soft contact lenses worn daily.	Device: Test Lens 1; Investigational soft contact lens with asperic optical design to control myopia progression.
Experimental: Test Lens 2; Investigational soft contact lenses worn daily.	Device: Test Lens 2; Investigational soft contact lens with asperic optical design to control myopia progression.
Active Comparator: Control lens; Spectacle lenses worn daily.	Device: Control Lens; Spectacle Lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Principal Investigator: Xu Cheng, MD, PhD, Principal Clinical Scientist

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-1561AB