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OpenTrials
Completed

NCT Number: NCT01787760

Controlling Myopia Progression With Soft Contact Lenses

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject must be between 8 and 12 years of age and of Asia origin.
  • The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
  • Astigmatism must be less than or equal to 1.00D
  • Less than 1.00D difference in spherical equivalent between the two eyes
  • The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes
  • The subject must have at least 8D of accommodation.
  • 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 the clinical protocol

Exclusion criteria

  • Ocular or systemic allergies or diseases that may interfere with contact lens wear
  • Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might 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.
  • 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 immunosuppressive disease (e.g. HIV).
  • Diabetes.
  • Anismetropia.
  • Astigmatism of greater than 1.00D in either eye.
  • Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
  • Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
  • Strabismus in either eye
  • Pupil or lid abnormality or infection in either eye
  • Central corneal scar and 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 clinical trials aimed to control myopia progression
  • Surgically altered eyes, ocular infection of any type, ocular inflammation
  • Subject has anterior chamber angle grade 2 or narrower

Treatment and study plan

Test Soft Contact Lens B

Device

Test lenses to be worn in daily wear modality

Test Soft Contact Lens C

Device

Test lenses to be worn in a daily wear modality

Active Comparator

Device

Control spectacle lenses to be worn in a daily wear modality

Primary outcomes

  1. Axial Length (Axial Elongation)

    Time frame: Baseline and every 6 months post-baseline up to 3 years

    Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.

  2. Spherical Equivalent Refraction

    Time frame: Baseline and every 6 months post-baseline up to 3 years

    Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 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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