CompletedNCT05779072Updated Nov 1, 2023Results posted

Dual Focus Soft Contact Lens Wear Cessation Study

An interventional study of Single Vision Soft Contact Lens in Myopia, sponsored by CooperVision, Inc.. Completed at 4 sites in 4 countries. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by CooperVision, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

Registered 4 years after the study started (first participant enrolled Mar 2019, registered Mar 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 83
Allocation: Non-randomized
Ages: 14 Years to 19 Years
Sex: All

Study summary

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 studied

Myopia

Browse trials for

Myopia 984

Keywords

Myopia Control

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 83 is close to the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

CooperVision, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 29 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 14 Years to 19 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 83 participants (actual)

Study arms

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
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

Interventions

DeviceSingle Vision Soft Contact Lens
Subjects refit to Single Vision Soft Contact Lens for 1 year

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 1 year

Results

Posted Nov 1, 2023

Participant flow

Participant flow — Overall Study
Milestone	Dual Focus for 3 Years	Dual Focus for 6 Years
Started	40	43
Completed	39	37
Not completed	1	6
Withdrew: Lost to follow-up	0	1
Withdrew: Withdrawal by subject	1	5

Outcome measures

PrimaryChange 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.

Time frame:: 1 year
Reported as:: Mean · D

Change in Spherical Equivalent Refractive Error (SERE)
D	Dual Focus for 3 Years	Dual Focus for 6 Years
Change in Spherical Equivalent Refractive Error (SERE)	-0.23 ± 0.363	-0.21 ± 0.397

PrimaryChange 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.

Time frame:: 1 year
Reported as:: Mean · mm

Change in Axial Length (AL)
mm	Dual Focus for 3 Years	Dual Focus for 6 Years
Change in Axial Length (AL)	0.09 ± 0.090	0.10 ± 0.103

Adverse events

Collected over The data was collected in time frame of 1 year of study.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dual Focus for 3 Years	0/40 (0%)	0/40 (0%)	2/40 (5%)
Dual Focus for 6 Years	0/43 (0%)	0/43 (0%)	3/43 (7%)

Most frequent other events

Most frequent other events
Event	Dual Focus for 3 Years	Dual Focus for 6 Years
ConjuctivitisInfections and infestations	1/40	1/43
Corneal StainingProduct Issues	1/40	1/43
DiscomfortProduct Issues	0/40	1/43

Baseline characteristics

Eighty-three participants were enrolled, and demographic data include all enrolled participants.

Age, Continuous
Age, Continuous(years)	Dual Focus for 3 Years	Dual Focus for 6 Years	Total
Mean	16.1 ± 1.58	16.3 ± 1.2	16.2 ± 1.39

Sex: Female, Male
Sex: Female, Male(Participants)	Dual Focus for 3 Years	Dual Focus for 6 Years	Total
Female	20	22	42
Male	20	21	41

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Dual Focus for 3 Years	Dual Focus for 6 Years	Total
Caucasian (European)	27	28	55
East Asian	10	13	23
Indian/Pakistani/SriLankan	5	3	8
Middle Eastern	1	0	1
Hispanic - Latino	0	1	1
Mediterranean	1	0	1
Black British	0	1	1

Study locations

4 sites

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

References and documents

Study documents

Protocol and statistical analysis plan · Jun 11, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05779072
Lead sponsor: CooperVision, Inc.
Collaborators: Visioncare Research Ltd.
Responsible party: Sponsor
First posted: Mar 22, 2023
Start date: Mar 1, 2019
Primary completion: Mar 1, 2021
Completion: Mar 1, 2021
Results posted: Nov 1, 2023
Last update: Nov 1, 2023

Study contacts

Graeme Young

study director · Visioncare Research Ltd.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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