MyopiaNCT05779072
Dual Focus Soft Contact Lens Wear Cessation Study
A study testing Single Vision Soft Contact Lens in people with Myopia, run by CooperVision, Inc. at 4 sites in 4 countries.
Trial summary
The purpose of this study is to investigate the effect of ceasing treatment with dual focus soft contact lenses. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Single Vision Soft Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Mar 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Canada1 site
University of Waterloo School of Optometry
Waterloo, Ontario, N2L 3G1
Portugal1 site
University of Minho Clinical & Experiment Optometry Research Lab
Braga, 4710-057
Singapore1 site
National University of Singapore Faculty of Medicine
Singapore, 117597
United Kingdom1 site
Aston University Ophthalmic Research Group
Birmingham, B4 7ET
About this study
Official title: MiSight Lens Wear Cessation Study
The purpose of this study is to investigate the effect of ceasing treatment with dual focus soft contact lenses.
Read the 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.
- Conditions
- Myopia
- Being tested
- Single Vision Soft Contact Lens
- Keywords
- Myopia Control
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Vision Soft Contact LensDevice
Subjects refit to Single Vision Soft Contact Lens for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Dual Focus for 3 years | Other | Group of subjects who completed dual focus soft contact lens wear treatment for 3 years Receives: 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 Receives: Device: Single Vision Soft Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Mar 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
- Investigators
- Graeme Young, Study director, Visioncare Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779072
- Sponsor's protocol ID
- MIST-402
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiSight Lens Wear Cessation Study
- ClinicalTrials.gov ID
- NCT05779072
- Acronym / sponsor ID
- MIST-402
- Conditions
- Myopia
- Keywords
- Myopia Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Focus for 3 years | Other | Device: Single Vision Soft Contact LensGroup of subjects who completed dual focus soft contact lens wear treatment for 3 years |
| Dual Focus for 6 years | Other | Device: Single Vision Soft Contact LensGroup of subjects who completed dual focus soft contact lens wear treatment for 6 years |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- 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:
- Where applicable (dependent on local requirements), have their parent or legal guardian:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Vision Soft Contact LensSubjects refit to Single Vision Soft Contact Lens for 1 year | Device | Dual Focus for 3 years, Dual Focus for 6 years |
Primary outcome
Change in Spherical Equivalent Refractive Error (SERE)
Time frame: 1 year
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.
Change in Axial Length (AL)
Time frame: 1 year
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graeme Young study director
Visioncare Research Ltd.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Vision Soft Contact Lens in people with Myopia, run by CooperVision, Inc. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Portugal, Singapore, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spherical Equivalent Refractive Error (SERE) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.