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MyopiaNCT07747311

Contact Lenses to Slow Myopia Progression in Adults

A study testing Dual Focus Soft Contact Lens and Single Vision Soft Contact Lens in people with Myopia and Myopia Progression, run by University of California, Berkeley at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Myopia (nearsightedness) can continue to worsen during young adulthood, increasing the risk of sight-threatening eye diseases later in life. Although dual-focus soft contacts (DFSC) lenses have been shown to slow myopia progression in children, their effectiveness in adults is not well understood. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Myopia, Myopia Progression
What is being tested?
Dual Focus Soft Contact Lens and Single Vision Soft Contact Lens
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 30 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Any gender, aged 18-30 years, inclusive.
  • Successful previous contact lens wearer
  • Documented ongoing myopia progression (at least 0.50D over past 2 years)
  • Refractive error meeting the following by cycloplegic autorefraction:
  • Myopia -0.50D to -5.00D SER in both eyes
  • Astigmatism (absolute value) ≤ 1.50 D in both eyes
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  • Anisometropia < 1.50 D SER.
  • Best-corrected distance visual acuity (BCDVA) in current correction as follows:
  • 0.1 logMAR or better
  • Interocular difference ≤ 0.1 log MAR

Who cannot join

  • Current or previous use of pharmacologic or optical myopia control treatment within the past 2 years.
  • Any ocular disease or abnormality affecting the cornea, lens, retina, iris, ciliary body, choroid, or sclera.
  • History of manifest strabismus, amblyopia, or nystagmus.
  • Previous eyelid, strabismus, intraocular, or refractive surgery. I- ntraocular pressure >26 mmHg.
  • of premature birth (≥6 weeks before the due date).
  • Neurological disorders, genetic syndromes, or other conditions that would interfere with completion of study procedures.
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  • Known allergy or hypersensitivity to fluorescein, proparacaine, or tropicamide.
  • Conditions associated with degenerative myopia or abnormal ocular anatomy (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, keratoconus, lenticonus, or spherophakia).
  • Regular use of ocular medications, artificial tears, or wetting agents.
  • Current use of systemic medications that may affect contact lens wear, tear film, pupil size, accommodation, electrophysiology, or refractive state.
  • Diagnosis of or treatment for attention-deficit/hyperactivity disorder (ADHD) or a learning disability.
  • Systemic disease that may affect visual function (e.g., diabetes mellitus).
  • Ocular inflammation within 30 days before screening.
  • Slit-lamp findings that contraindicate contact lens wear (e.g., corneal scars, corneal neovascularization, giant papillary conjunctivitis).
  • Blepharospasm or other eyelid abnormalities that interfere with contact lens wear.
  • Any severe ocular or systemic condition that, in the investigator's judgment, would interfere with study participation or follow-up.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ranjila Shyangbo contact

510-833-8625

ranjila@berkeley.edu

Sarah Singh, OD, PhD, FAAO contact

914-213-8625

sarah_singh@berkeley.edu

United States1 site

  • University Of California, Berkeley Myopia Research Group

    Berkeley, California, 94720

    Ranjila Shyangbo, 510-833-8625, ranjila@berkeley.edu

    ranjila@berkeley.edu

Other trials in United States

About this study

Official title: Dual-focus Soft Contact Lenses for the Treatment of Adult Myopia Progression

Myopia (nearsightedness) can continue to worsen during young adulthood, increasing the risk of sight-threatening eye diseases later in life. Although dual-focus soft contacts (DFSC) lenses have been shown to slow myopia progression in children, their effectiveness in adults is not well understood. This study will compare DFSC lenses with standard single-vision soft contact (SVSC) lenses in myopic young adults aged 18 to 30 years. Participants will be randomly assigned to wear one of the two lens types for 24 months. The study will measure changes in axial length and cycloplegic refractive error to determine whether DFSC lenses slow myopia progression in young adults.

Read the detailed description

This is a prospective, single-center, randomized, double-masked, parallel-group clinical trial designed to evaluate the efficacy of DFSC lenses for slowing myopia progression in young adults. Approximately 152 participants aged 18 to 30 years with documented ongoing myopia progression. will be randomized in a 1:1 ratio to wear either MiSight 1 day DFSC lenses or Proclear 1 day SVSC lenses for 24 months. The co-primary outcomes are changes in axial length and cycloplegic spherical equivalent refractive error over 24 months. Secondary outcomes include changes in choroidal parameters, including thickness, accommodation, and ocular safety. Outcome assessors will remain masked to treatment allocation throughout the study.

Being tested
Dual Focus Soft Contact Lens, Single Vision Soft Contact Lens
Keywords
myopia, adult myopia, myopia progression, MiSight
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual Focus Soft Contact LensDevice

    MiSight 1 day is a daily disposable dual-focus soft contact lens with two treatment zones and two distance vision correction zones arranged in concentric rings.

  • Single Vision Soft Contact LensDevice

    Proclear 1 day is a daily disposable single-vision soft contact lens that provides conventional correction of refractive error without myopia control treatment zones.

Study groups in NCT07747311
Study groupRoleWhat they receive
TreatmentExperimentalParticipants will wear MiSight 1 day dual-focus soft contact lenses on a daily-wear basis for 24 months according to the study protocol.
Receives: Device: Dual Focus Soft Contact Lens
ControlPlacebo comparatorParticipants will wear Proclear 1-day single-vision soft contact lenses on a daily wear basis for 24 months according to the study protocol.
Receives: Device: Single Vision Soft Contact Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cycloplegic Spherical Equivalent Refraction

    Change in cycloplegic spherical equivalent refraction (diopters) from baseline, measured by cycloplegic autorefraction after instillation of 1% tropicamide. Spherical equivalent will be calculated as sphere + one-half cylinder. The mean change from baseline will be compared between the DFSC and SVSC lens groups.

    Measured: Baseline, 12 months, and 24 months

  2. Axial Length

    Change in axial length (millimeters) from baseline. The mean change from baseline will be compared between two groups

    Measured: Baseline, 12 months, and 24 months

Secondary outcomes (5)

  1. Acute Change in Choroidal Thickness

    Change in subfoveal choroidal thickness (µm) measured using swept-source optical coherence tomography (SS-OCT) immediately before and after a 30-minute adaptation period while wearing the assigned contact lens.

    Measured: Baseline (pre-lens adaptation) and immediately following 30 minutes of contact lens wear (post-lens adaptation).

  2. Quality of Vision

    Change from baseline in quality of vision assessed using the Quality of Vision (QoV) Questionnaire, a previously validated patient-reported outcome measure comprising three Rasch-scaled subscales (Frequency, Severity, and Bothersome), each ranging from 0 to 100, with higher scores indicating worse quality of vision. Subscale scores will be compared between treatment groups at the prespecified study visits.

    Measured: Baseline, 2 weeks, 12 months, and 24 months

  3. Accommodative Response

    Change from baseline in dynamic accommodative response (diopters) measured objectively over a range of accommodative demands using the Shack-Hartmann aberrometer. Responses will be compared between treatment groups.

    Measured: Baseline, 2 weeks, 6 months, 12 months, and 24 months

  4. Ocular Safety

    Cumulative incidence of ocular and contact lens-related adverse events occurring from baseline through 12 months and from baseline through 24 months will be compared between treatment groups.

    Measured: Baseline through 12 months and Baseline through 24 months

  5. Longitudinal Change in Choroidal Thickness

    Change in subfoveal choroidal thickness (µm) measured using swept-source optical coherence tomography (SS-OCT) over the study period to evaluate the longitudinal effect of the assigned contact lens.

    Measured: Baseline, 6 months, 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07747311
Sponsor's protocol ID
2022-09-15618
Status last verified
Jul 2026
First submitted
23 Jul 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in publications arising from this study will be made available. Data will be shared only after all direct identifiers have been removed and reasonable measures have been taken to minimize the risk of participant re-identification. Data sharing will be conducted in accordance with applicable institutional policies, participant consent, and regulatory requirements to protect participant confidentiality. De-identified individual participant data will be shared as CSV files.

Publications

  • McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.

    PubMed 20505205

  • Brennan NA, Cheng X, Bullimore MA. Adult Myopia Progression. Invest Ophthalmol Vis Sci. 2024 Nov 4;65(13):49. doi: 10.1167/iovs.65.13.49.

    PubMed 39576624

  • Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2.

    PubMed 37126362

Questions about this trial

What is this clinical trial studying?

A study testing Dual Focus Soft Contact Lens and Single Vision Soft Contact Lens in people with Myopia and Myopia Progression, run by University of California, Berkeley at 1 site in United States.

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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ranjila Shyangbo (510-833-8625, ranjila@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cycloplegic Spherical Equivalent Refraction (time frame: Baseline, 12 months, and 24 months). 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?

On the ClinicalTrials.gov record for NCT07747311, which also lists 3 linked publications.

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 5 Aug 2026.

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