Myopia Progression After Ceasing Myopia Control Contact Lens Wear
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ClinicalTrials.gov Identifier: NCT01829230 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Results First Posted : September 25, 2014
Last Update Posted : June 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myopia | Device: 1 Day Acuvue Moist | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Myopia Progression After Ceasing Myopia Control Contact Lens Wear |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Test lens C
Test lens C from previous study
|
Device: 1 Day Acuvue Moist
Lenses will be worn in a daily wear modality |
Active Comparator: Test lens A
Test lens A from previous study
|
Device: 1 Day Acuvue Moist
Lenses will be worn in a daily wear modality |
- Axial Length of the Eye [ Time Frame: Baseline and every 6 months post-baseline up to 18 months ]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.
- Spherical Equivalent Refractive Error [ Time Frame: Baseline and every 6 months up to 18 months ]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.

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Ages Eligible for Study: | 9 Years to 13 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- The subject must be enrolled in the parent protocol for at least one year.
- 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.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria:
- Ocular or systemic allergies that may interfere with contact lens wear.
- Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
- 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.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
- Diabetes
- Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
- Strabismus.
- Pupil or lid abnormality or infection in either eye
- Central corneal scar in either eye
- Aphakia in either eye
- Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
- History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
- Surgically altered eyes, ocular infection of any type, ocular inflammation.
- Anterior chamber angle grade 2 or narrower by Van Herrick method.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829230
United States, Massachusetts | |
Boston, Massachusetts, United States, 02215 |
Responsible Party: | Johnson & Johnson Vision Care, Inc. |
ClinicalTrials.gov Identifier: | NCT01829230 |
Other Study ID Numbers: |
CR-1561AF |
First Posted: | April 11, 2013 Key Record Dates |
Results First Posted: | September 25, 2014 |
Last Update Posted: | June 19, 2018 |
Last Verified: | July 2015 |
Myopia Refractive Errors Eye Diseases |