An interventional study of Dual Focus Soft Contact Lens and Single Vision Soft Contact Lens in Myopia and Myopia Progression, sponsored by University of California, Berkeley. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of California, Berkeley · Not applicable, Interventional, and Treatment
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.
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 152 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →University of California, Berkeley is the lead sponsor of 111 studies on the registry; 20 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Best-corrected distance visual acuity (BCDVA) in current correction as follows:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will wear MiSight 1 day dual-focus soft contact lenses on a daily-wear basis for 24 months according to the study protocol.
Device: Dual Focus Soft Contact Lens
Participants will wear Proclear 1-day single-vision soft contact lenses on a daily wear basis for 24 months according to the study protocol.
Device: Single Vision Soft Contact Lens
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.
Proclear 1 day is a daily disposable single-vision soft contact lens that provides conventional correction of refractive error without myopia control treatment zones.
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.
Time frame: Baseline, 12 months, and 24 months
Axial Length
Change in axial length (millimeters) from baseline. The mean change from baseline will be compared between two groups
Time frame: Baseline, 12 months, and 24 months
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.
Time frame: Baseline (pre-lens adaptation) and immediately following 30 minutes of contact lens wear (post-lens adaptation).
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.
Time frame: Baseline, 2 weeks, 12 months, and 24 months
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.
Time frame: Baseline, 2 weeks, 6 months, 12 months, and 24 months
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.
Time frame: Baseline through 12 months and Baseline through 24 months
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.
Time frame: Baseline, 6 months, 12 months and 24 months
Choroidal vascularity index (CVI)
Change from baseline in choroidal vascularity index (CVI), measured using swept-source optical coherence tomography (SS-OCT), to evaluate longitudinal changes during contact lens treatment.
Time frame: Baseline, 6 months, 12 months, and 24 months.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available beginning 6 months after publication of the primary study results and will remain available for up to 7 years after publication.
Access criteria: De-identified data will be made available to qualified researchers for scientifically sound research purposes. Investigators requesting access must submit a methodologically appropriate research proposal describing the intended use of the data. Requests will be reviewed by the study investigators, and access may require approval by the University of California, Berkeley, execution of a data use agreement, and compliance with applicable institutional and regulatory requirements. Data will be provided only for purposes consistent with the informed consent provided by study participants.
Start is estimated for Sep 2026; primary completion for Sep 2030, 48 months later.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 48 months is above that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Berkeley →