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

Primary Purpose

Myopia, Progressive

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

MiSight contact lenses

Proclear contact lenses

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

18 Years - 21 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MiSight dual focus contact lens

Proclear single vision contact lens

Arm Description

Outcomes

Primary Outcome Measures

Change in axial length relative to baseline

Change in spherical equivalent cycloplegic autorefraction relative to baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT05955638

First Posted

July 13, 2023

Last Updated

July 13, 2023

Sponsor

University of Bradford

Collaborators

University of Huddersfield, Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05955638

Brief Title

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

Acronym

MoMUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

September 1, 2028 (Anticipated)

Study Completion Date

September 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Bradford

Collaborators

University of Huddersfield, Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Progressive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MiSight dual focus contact lens

Arm Type

Experimental

Arm Title

Proclear single vision contact lens

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

MiSight contact lenses

Intervention Description

Contact lens for myopia management.

Intervention Type

Device

Intervention Name(s)

Proclear contact lenses

Intervention Description

Single vision contact lens as control

Primary Outcome Measure Information:

Title

Change in axial length relative to baseline

Time Frame

Baseline, 24 months

Title

Change in spherical equivalent cycloplegic autorefraction relative to baseline

Time Frame

Baseline, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martin Brinkworth, PhD

Phone

+441274233584

nhs-ethics@bradford.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathryn Webber, MOptom

Organizational Affiliation

University of Bradford

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Matthew Cufflin, PhD

Organizational Affiliation

University of Bradford

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edward Mallen, PhD

Organizational Affiliation

University of Bradford

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Niall Hynes, PhD

Organizational Affiliation

University of Huddersfield

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31116165

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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

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