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MoMUS: Management of Myopia in University Students Using Dual Focus Soft Contact Lenses

Sponsor
University of Bradford (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05955638
Collaborator
University of Huddersfield (Other), Coopervision, Inc. (Industry)
84
Enrollment
2
Arms
60
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to quantify the effectiveness of Coopervision MiSight contact lenses in slowing the rate of myopia progression in university students.

Condition or Disease Intervention/Treatment Phase
  • Device: MiSight contact lenses
  • Device: Proclear contact lenses
 N/A

Detailed Description

MiSight contact lenses have been shown to be a safe and effective way of managing myopia progression in children aged 8-12 years. However, myopic progression is not limited to children of this age group and MiSight lenses have also been shown to be effective in older children aged 11-16 years. There is evidence that progression also occurs in university students. We are therefore investigating the effectiveness of this intervention in a group of UK-based University students.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Management of Myopia in University Students Using Dual Focus Soft Contact Lenses
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2028
Anticipated Study Completion Date :
Sep 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: MiSight dual focus contact lens

Device: MiSight contact lenses
Contact lens for myopia management.
Active Comparator: Proclear single vision contact lens

Device: Proclear contact lenses
Single vision contact lens as control

Outcome Measures

Primary Outcome Measures

  1. Change in axial length relative to baseline [Baseline, 24 months]

  2. Change in spherical equivalent cycloplegic autorefraction relative to baseline [Baseline, 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Be a myopic students studying at university

  • Be aged 18-21 years at the start of the study

  • Show evidence of recent myopia progression prior to commencement of Stage 2 of the study.

  • Have read the patient information sheet and be happy to sign the consent forms

  • Be willing to adhere to the visit schedule and wearing times described in this protocol

  • Agree to lens wearing times of at least 10 hours per day, 6 days per week

  • Agree to accept either the control or test lens as assigned by the randomisation

  • Have BCVA of +0.10 logMAR or better in each eye

Exclusion Criteria:

  • Previous myopia control use (optical or pharmacological)

  • Amblyopia

  • Ocular pathology such as keratoconus or recurrent corneal infections

  • Myopic Rx > 10D

  • Astigmatism >1D

  • Anisometropia >1.75D

  • Binocular Vision anomalies (such as Tropia)

  • Medications that affect pupil size or accommodation

  • A known allergy to fluorescein or tropicamide

  • Biomicroscopic findings that would contraindicate contact lens wear

  • The investigator considers that it is not in the best interest of the subject to participate in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Bradford
  • University of Huddersfield
  • Coopervision, Inc.

Investigators

  • Principal Investigator: Kathryn Webber, MOptom, University of Bradford
  • Principal Investigator: Matthew Cufflin, PhD, University of Bradford
  • Principal Investigator: Edward Mallen, PhD, University of Bradford
  • Principal Investigator: Niall Hynes, PhD, University of Huddersfield

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Bradford
ClinicalTrials.gov Identifier:
NCT05955638
Other Study ID Numbers:
  • E1060
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia
Myopia, Degenerative

Study Results

No Results Posted as of Jul 21, 2023