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NCT07747311

Contact Lenses to Slow Myopia Progression in Adults

Sponsor: University of California, Berkeley

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2026-09-01

Completion Date

2030-09-30

Last Updated

2026-08-05

Healthy Volunteers

Conditions

Myopia Myopia Progression

Interventions

DEVICE

Dual Focus 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.

DEVICE

Single Vision Soft Contact Lens

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

Inclusion Criteria: * 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: * 0.1 logMAR or better * Interocular difference ≤ 0.1 log MAR Exclusion Criteria: * 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. * Any severe ocular or systemic condition that, in the investigator's judgment, would interfere with study participation or follow-up.

Locations (1)

University Of California, Berkeley Myopia Research Group

Berkeley, California, United States