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Dual Focus Soft Contact Lens Wear Cessation Study

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Single Vision Soft Contact Lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia focused on measuring Myopia Control

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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: 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, indicated an understanding of the Informed Consent and 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: 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.

Sites / Locations

  • University of Waterloo School of Optometry
  • University of Minho Clinical & Experiment Optometry Research Lab
  • National University of Singapore Faculty of Medicine
  • Aston University Ophthalmic Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Dual Focus for 3 years

Dual Focus for 6 years

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Coopervision, Inc.
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05779072
Brief Title
Dual Focus Soft Contact Lens Wear Cessation Study
Official Title
MiSight Lens Wear Cessation Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
Collaborators
Visioncare Research Ltd.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia Control

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual Focus for 3 years
Arm Type
Other
Arm Description
Group of subjects who completed dual focus soft contact lens wear treatment for 3 years
Arm Title
Dual Focus for 6 years
Arm Type
Other
Arm Description
Group of subjects who completed dual focus soft contact lens wear treatment for 6 years
Intervention Type
Device
Intervention Name(s)
Single Vision Soft Contact Lens
Intervention Description
Subjects refit to Single Vision Soft Contact Lens for 1 year
Primary Outcome Measure Information:
Title
Change in spherical equivalent refractive error (SERE)
Description
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)
Time Frame
1 year
Title
Change in axial length (AL)
Description
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)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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, indicated an understanding of the Informed Consent and 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Young
Organizational Affiliation
Visioncare Research Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
University of Waterloo School of Optometry
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Facility Name
University of Minho Clinical & Experiment Optometry Research Lab
City
Braga
ZIP/Postal Code
4710-057
Country
Portugal
Facility Name
National University of Singapore Faculty of Medicine
City
Singapore
ZIP/Postal Code
117597
Country
Singapore
Facility Name
Aston University Ophthalmic Research Group
City
Birmingham
ZIP/Postal Code
B4 7ET
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Dual Focus Soft Contact Lens Wear Cessation Study

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