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

This study is currently recruiting participants.
Verified April 2013 by Coopervision, Inc.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01729208
First received: November 14, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  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 Phase
Myopia
 Device: Dual Focus Soft Contact Lens
Device: Single Vision Soft Contact Lens
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Change in refractive error relative to baseline [ Time Frame: yearly for 3 years ] [ Designated as safety issue: No ]
  • Change in axial length relative to baseline [ Time Frame: yearly for 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2016 (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

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729208

Contacts
Contact: Susanna Jones s.jones@visioncare.co.uk
Contact: Thomas Boyes t.boyes@visioncare.co.uk

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

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01729208     History of Changes
Other Study ID Numbers: CVI08008
Study First Received: November 14, 2012
Last Updated: April 10, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013