Boston, Massachusetts, 02215, United States
NCT Number: NCT01829230
Myopia Progression After Ceasing Myopia Control Contact Lens Wear
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.
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Conditions
Age range
9 year–13 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
1 Day Acuvue Moist
DeviceLenses will be worn in a daily wear modality
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Industry
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Apr 11, 2013
- Registry last updated
- Jun 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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