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OpenTrials
Enrolling by Invitation

NCT Number: NCT05955638

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

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.

Enrolling by Invitation

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Key information

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bradford, Bradford, West Yorkshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MiSight contact lenses

Device

Contact lens for myopia management.

Proclear contact lenses

Device

Single vision contact lens as control

Primary outcomes

  1. Change in axial length relative to baseline

    Time frame: Baseline, 24 months

  2. Change in spherical equivalent cycloplegic autorefraction relative to baseline

    Time frame: Baseline, 24 months

Sponsors and collaborators

Lead sponsor

University of Bradford

Other

Collaborators

  • CooperVision International Limited (CVIL)
  • University of Huddersfield

Registry information

Acronym: MoMUS

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 21, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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