ClinicalTrials.gg
Enrolling by invitationNCT05955638MoMUSUpdated Jun 23, 2026

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

An interventional study of MiSight contact lenses and Proclear contact lenses in Myopia, Progressive, sponsored by University of Bradford. Enrolling by invitation at 2 sites in United Kingdom. Open to participants aged 18 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by University of Bradford · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myopia, Progressive

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03

In context

Myopia, Degenerative

71 studies on the registry are indexed under Myopia, Degenerative; 20 are open to participants now.

This study's planned enrollment of 84 is below the median of 122 across 57 interventional studies indexed under Myopia, Degenerative.

Browse Myopia, Degenerative studies →

Lead sponsor

University of Bradford is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    MiSight dual focus contact lens

    Device: MiSight contact lenses

  • Active comparator
    Proclear single vision contact lens

    Device: Proclear contact lenses

Interventions

  • DeviceMiSight contact lenses

    Contact lens for myopia management.

  • DeviceProclear contact lenses

    Single vision contact lens as control

06

What researchers measure

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

07

Study locations

2 sites
08

References and documents

Publications

  • Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019 Jun;96(6):463-465. doi: 10.1097/OPX.0000000000001367. PubMed 31116165 ↗
  • Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410. PubMed 31343513 ↗
  • Chamberlain P, Bradley A, Arumugam B, Hammond D, McNally J, Logan NS, Jones D, Ngo C, Peixoto-de-Matos SC, Hunt C, Young G. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. doi: 10.1097/OPX.0000000000001873. PubMed 35086120 ↗
  • Jacobsen N, Jensen H, Goldschmidt E. Does the level of physical activity in university students influence development and progression of myopia?--a 2-year prospective cohort study. Invest Ophthalmol Vis Sci. 2008 Apr;49(4):1322-7. doi: 10.1167/iovs.07-1144. PubMed 18385044 ↗
  • Jorge J, Almeida JB, Parafita MA. Refractive, biometric and topographic changes among Portuguese university science students: a 3-year longitudinal study. Ophthalmic Physiol Opt. 2007 May;27(3):287-94. doi: 10.1111/j.1475-1313.2007.00475.x. PubMed 17470242 ↗
  • Kinge B, Midelfart A, Jacobsen G, Rystad J. Biometric changes in the eyes of Norwegian university students--a three-year longitudinal study. Acta Ophthalmol Scand. 1999 Dec;77(6):648-52. doi: 10.1034/j.1600-0420.1999.770608.x. PubMed 10634556 ↗
  • McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26. PubMed 20505205 ↗
  • McCullough SJ, O'Donoghue L, Saunders KJ. Six Year Refractive Change among White Children and Young Adults: Evidence for Significant Increase in Myopia among White UK Children. PLoS One. 2016 Jan 19;11(1):e0146332. doi: 10.1371/journal.pone.0146332. eCollection 2016. PubMed 26783753 ↗
  • Pesudovs K, Garamendi E, Elliott DB. A quality of life comparison of people wearing spectacles or contact lenses or having undergone refractive surgery. J Refract Surg. 2006 Jan-Feb;22(1):19-27. doi: 10.3928/1081-597X-20060101-07. PubMed 16447932 ↗
  • Ruiz-Pomeda A, Perez-Sanchez B, Valls I, Prieto-Garrido FL, Gutierrez-Ortega R, Villa-Collar C. MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):1011-1021. doi: 10.1007/s00417-018-3906-z. Epub 2018 Feb 3. PubMed 29396662 ↗
  • Tilia D, Diec J, Ehrmann K, Falk D, Fedtke C, Conrad F, Wu R, Bakaraju RC. Visual Performance and Binocular/Accommodative Function of S.T.O.P. Contact Lenses Compared With MiSight. Eye Contact Lens. 2023 Feb 1;49(2):63-70. doi: 10.1097/ICL.0000000000000950. Epub 2022 Oct 19. PubMed 36282205 ↗
  • Wolffsohn JS, Kollbaum PS, Berntsen DA, Atchison DA, Benavente A, Bradley A, Buckhurst H, Collins M, Fujikado T, Hiraoka T, Hirota M, Jones D, Logan NS, Lundstrom L, Torii H, Read SA, Naidoo K. IMI - Clinical Myopia Control Trials and Instrumentation Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M132-M160. doi: 10.1167/iovs.18-25955. PubMed 30817830 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05955638
Lead sponsor
University of Bradford
Collaborators
University of Huddersfield, CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Jul 21, 2023
Start date
Jan 1, 2024
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Jun 23, 2026

Study contacts

Kathryn Webber, MOptom
principal investigator · University of Bradford
Matthew Cufflin, PhD
principal investigator · University of Hudderfield
Niall Hynes, PhD
principal investigator · University of Huddersfield
Neema Ghorbani-Mojarrad, PhD
principal investigator · University of Bradford

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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