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An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01729208
First Posted: November 20, 2012
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Coopervision, Inc.
  Purpose
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Condition Intervention
Myopia Device: Dual Focus Soft Contact Lens Device: Single Vision Soft Contact Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Change in refractive error relative to baseline [ Time Frame: yearly for 3 years ]
  • Change in axial length relative to baseline [ Time Frame: yearly for 3 years ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 3 years ]

Estimated Enrollment: 300
Actual Study Start Date: November 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
Device: Dual Focus Soft Contact Lens
Placebo Comparator: Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
Device: Single Vision Soft Contact Lens

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be between 8 and 12 years of age inclusive.
  • Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
  • Spherical Equivalent Refractive Error between -0.75 and -4.00 D inclusive astigmatism: < -0.75 D anisometropia: < 1.00 D
  • Possess wearable and visually functional eyeglasses.
  • Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.

Exclusion Criteria:

  • Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
  • Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
  • Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
  • Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
  • Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
  • A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
  • Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
  • Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01729208


Locations
Canada, Ontario
University of Waterloo School of Optometry
Waterloo, Ontario, Canada, N2L 3G1
Portugal
University of Minho Clinical & Experiment Optometry Research Lab
Braga, Portugal, 4710-057
Singapore
National University of Singapore Faculty of Medicine
Singapore, Singapore, 117597
United Kingdom
Aston University Ophthalmic Research Group
Birmingham, United Kingdom, B4 7ET
Sponsors and Collaborators
Coopervision, Inc.
Visioncare Research Ltd.
  More Information

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01729208     History of Changes
Other Study ID Numbers: CVI08008
First Submitted: November 14, 2012
First Posted: November 20, 2012
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Coopervision, Inc.:
myopia progression
myopia control

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases