Dual Focus Soft Contact Lens Wear Cessation Study

MiSight Lens Wear Cessation Study

The purpose of this study is to investigate the effect of ceasing treatment with dual focus soft contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Single Vision Soft Contact Lens

Detailed Description

This is a bilateral, open label, dispensing study with subjects who have completed dual focus soft contact lens wear treatment for either 3 or 6 years and who are refit to Proclear 1-day lens for 1 year.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo School of Optometry
• Portugal
  • Braga, Portugal, 4710-057
    • University of Minho Clinical & Experiment Optometry Research Lab
• Singapore
  • Singapore, Singapore, 117597
    • National University of Singapore Faculty of Medicine
• United Kingdom
  • Birmingham, United Kingdom, B4 7ET
    • Aston University Ophthalmic Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Successfully completed the MIST-401 Parts 1 and 2
• Visual acuity (VA) with CLs better than +0.25 log MAR (>6/12 or >20/40) in both eyes
• No ocular pathology or other contraindication to contact lens wear

• Where applicable (dependent on local requirements), have:

  1. read the Informed Assent
  2. been given an explanation of the Informed Assent,
  3. indicated an understanding of the Informed Assent and
  4. signed the Informed Assent Form. Or
  5. read the Informed Consent,
  6. been given an explanation of the Informed Consent,
  7. indicated an understanding of the Informed Consent and
  8. signed the Informed Consent Form.

• Where applicable (dependent on local requirements), have their parent or legal guardian:

  1. read the Informed Consent,
  2. been given an explanation of the Informed Consent,
  3. indicated an understanding of the Informed Consent and
  4. signed the Informed Consent Form.
• Along with their parent or guardian (if applicable), be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol.
• Along with their parent or guardian (if applicable), agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
• Agree to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
• Be in good general health, based on his/her and parent's/guardian's (if applicable) knowledge.
• Have best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.

Exclusion Criteria:

• Regular use of ocular medications (prescription or over-the-counter).
• Current use of systemic medications which, in the investigators opinion, may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
• Pregnant or lactating or planning a pregnancy at the time of enrolment.
• Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjogren's syndrome, lupus erythematosus, scleroderma, or diabetes.
• Any ocular, systemic or neuro-developmental conditions that in the investigators opinion, could influence refractive development.
• Keratoconus or an irregular cornea.

• Biomicroscope findings that would contraindicate contact lens wear including, but not limited to:

  1. Any active anterior segment ocular disease that would contraindicate contact lens wear.
  2. clinically significant (Grade 3 or 4) abnormalities of the anterior segment, lids, conjunctiva, sclera or associated structures.
• The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dual Focus for 3 years; Group of subjects who completed dual focus soft contact lens wear treatment for 3 years	Device: Single Vision Soft Contact Lens; Subjects refit to Single Vision Soft Contact Lens for 1 year
Other: Dual Focus for 6 years; Group of subjects who completed dual focus soft contact lens wear treatment for 6 years	Device: Single Vision Soft Contact Lens; Subjects refit to Single Vision Soft Contact Lens for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spherical Equivalent Refractive Error (SERE)	Change in spherical equivalent refractive error (SERE) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Cycloplegic autorefraction was used to measure refractive error.	1 year
Change in Axial Length (AL)	Change in axial length (AL) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Partial coherence interferometry was used to measure axial length.	1 year

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Collaborators: Visioncare Research Ltd.
• Investigators: Study Director: Graeme Young, Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Myopia Control
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: MIST-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes