Dual Focus Soft Contact Lens Wear Cessation Study

NCT05779072 | Completed Results DMC FDA Device

• 1 other identifier: MIST-402
• Study Type: interventional
• Target: 83
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Myopia

Keywords

Myopia Control

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Dual Focus for 3 years

OTHER

Group of subjects who completed dual focus soft contact lens wear treatment for 3 years

Device: Single Vision Soft Contact Lens

Dual Focus for 6 years

OTHER

Group of subjects who completed dual focus soft contact lens wear treatment for 6 years

Device: Single Vision Soft Contact Lens

Interventions

Single Vision Soft Contact Lens DEVICE

Subjects refit to Single Vision Soft Contact Lens for 1 year

Dual Focus for 3 years; Dual Focus for 6 years

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• read the Informed Assent
• been given an explanation of the Informed Assent,
• indicated an understanding of the Informed Assent and
• signed the Informed Assent Form. Or
• read the Informed Consent,
• been given an explanation of the Informed Consent,
• indicated an understanding of the Informed Consent and
• signed the Informed Consent Form.
• Where applicable (dependent on local requirements), have their parent or legal guardian:
• read the Informed Consent,
• been given an explanation of the Informed Consent,

You may not qualify if:

• 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:
• Any active anterior segment ocular disease that would contraindicate contact lens wear.
• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (4)

University of Waterloo School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

Location

University of Minho Clinical & Experiment Optometry Research Lab

Braga, 4710-057, Portugal

Location

National University of Singapore Faculty of Medicine

Singapore, 117597, Singapore

Location

Aston University Ophthalmic Research Group

Birmingham, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Paul Chamberlain
• Organization: Coopervision

pchamberlain@coopervision.com

9257306754

Study Officials

• Graeme Young

  Visioncare Research Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); PT (1); GB (1); SG (1)