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

December 11, 2024 updated by: University of Bradford
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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. The researchers are therefore investigating the effectiveness of this intervention in a group of UK-based University students.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Huddersfield, United Kingdom
        • University of Huddersfield
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD7
        • University of Bradford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in axial length relative to baseline
Time Frame: Baseline, 24 months
Baseline, 24 months
Change in spherical equivalent cycloplegic autorefraction relative to baseline
Time Frame: Baseline, 24 months
Baseline, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bradford

Collaborators

University of Huddersfield
CooperVision International Limited (CVIL)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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