Contact Lenses to Slow Myopia Progression in Adults

NCT07747311 | Not Yet Recruiting FDA Device

• 1 other identifier: 2022-09-15618
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myopia; Myopia Progression

Keywords

myopia; adult myopia; myopia progression; MiSight

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline, 12 months, and 24 months

Secondary Outcomes (5)

• Acute Change in Choroidal Thickness

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

• Quality of Vision

  Baseline, 2 weeks, 12 months, and 24 months

• Accommodative Response

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

• Ocular Safety

  Baseline through 12 months and Baseline through 24 months

• Longitudinal Change in Choroidal Thickness

  Baseline, 6 months, 12 months and 24 months

Other Outcomes (1)

• Choroidal vascularity index (CVI)

  Baseline, 6 months, 12 months, and 24 months.

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Dual Focus Soft Contact Lens DEVICE

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.

Treatment

Single Vision Soft Contact Lens DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Anisometropia \< 1.50 D SER.
• Best-corrected distance visual acuity (BCDVA) in current correction as follows:
• logMAR or better
• Interocular difference ≤ 0.1 log MAR

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University Of California, Berkeley Myopia Research Group

Berkeley, California, 94720, United States

Location

Related Publications (3)

• 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.

  PMID: 20505205 BACKGROUND

• 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.

  PMID: 39576624 BACKGROUND

• 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.

  PMID: 37126362 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Sarah Singh

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

• Ranjila Shyangbo

  University of California, Berkeley

  STUDY DIRECTOR

Central Study Contacts

Ranjila Shyangbo

CONTACT

510-833-8625; ranjila@berkeley.edu

Sarah Singh, OD, PhD, FAAO

CONTACT

914-213-8625; sarah_singh@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)