NCT05955638

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jan 2024Sep 2028

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

4.7 years

First QC Date

July 13, 2023

Last Update Submit

December 11, 2024

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (2)

  • Change in axial length relative to baseline

    Baseline, 24 months

  • Change in spherical equivalent cycloplegic autorefraction relative to baseline

    Baseline, 24 months

Study Arms (2)

MiSight dual focus contact lens

EXPERIMENTAL
Device: MiSight contact lenses

Proclear single vision contact lens

ACTIVE COMPARATOR
Device: Proclear contact lenses

Interventions

MiSight contact lensesDEVICE

Contact lens for myopia management.

MiSight dual focus contact lens
Proclear contact lensesDEVICE

Single vision contact lens as control

Proclear single vision contact lens

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Bradford

Bradford, West Yorkshire, BD7, United Kingdom

Location

University of Huddersfield

Huddersfield, United Kingdom

Location

Related Publications (12)

  • Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019 Jun;96(6):463-465. doi: 10.1097/OPX.0000000000001367.

    PMID: 31116165BACKGROUND

  • 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.

    PMID: 31343513BACKGROUND

  • 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.

    PMID: 35086120BACKGROUND

  • 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.

    PMID: 18385044BACKGROUND

  • 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.

    PMID: 17470242BACKGROUND

  • 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.

    PMID: 10634556BACKGROUND

  • 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.

    PMID: 20505205BACKGROUND

  • 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.

    PMID: 26783753BACKGROUND

  • 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.

    PMID: 16447932BACKGROUND

  • 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.

    PMID: 29396662BACKGROUND

  • 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.

    PMID: 36282205BACKGROUND

  • 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.

    PMID: 30817830BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations

GB(2)