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OpenTrials
Completed

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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Key information

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston, Massachusetts, 02215, United States

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

Device

Lenses will be worn in a daily wear modality

Primary outcomes

  1. 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.

  2. 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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