Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Myopia Clinical Trial

Official title:

Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829230
• Other study ID #: CR-1561AF
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

Inclusion Criteria:

1. The subject must be enrolled in the parent protocol for at least one year.

2. 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.

3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies that may interfere with contact lens wear.

2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact 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. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.

10. Strabismus.

11. Pupil or lid abnormality or infection in either eye

12. Central corneal scar in either eye

13. Aphakia in either eye

14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.

15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial

16. Surgically altered eyes, ocular infection of any type, ocular inflammation.

17. Anterior chamber angle grade 2 or narrower by Van Herrick method.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• 1 Day Acuvue Moist
Lenses will be worn in a daily wear modality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Length of the Eye	Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.	Baseline and every 6 months post-baseline up to 18 months
Primary	Spherical Equivalent Refractive Error	Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.	Baseline and every 6 months up to 18 months