Recruiting

Wavelength Intervention

Sponsor:

University of Alabama at Birmingham

Code:

NCT06598423

Conditions

Myopia

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

Interventions

Specialized soft contact lens 1

Specialized soft contact lens 2

Study Details

Brief summary:

The goal of this clinical trial is to learn if daily brief periods of specialized soft contact lens wear work to slow the progression of nearsightedness in children. Additionally, the study will learn about the compliance and safety of specialized soft contact lens wear in children. The main questions it aims to answer are:

Does wearing specialized soft contact lenses daily slow myopia progression and axial elongation? What visual/ocular problems do participants have when wearing specialized soft contact lenses? Researchers will compare two soft contact lenses to see if specialized soft contact lens wear works to treat childhood myopia progression.

Participants will

1. Wear either a single type of soft contact lens or two types of soft contact lenses at alternate times daily full time in both eyes for one year.
2. Visit the clinic at 2 weeks, 1 month, 3 months, 6 months, and 12 months for checkups and tests
3. Keep a diary of the lens-wearing times.

Conditions

Myopia

Study ID

NCT06598423

Start date

Apr 10, 2025

Status verified date

Oct, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Spherical component of refractive error in primary meridian between -0.75 and -5.00 D
  • Less than 1.00 D of astigmatism or anisometropia
  • History of soft contact lens wear for at least a week
  • Best-corrected visual acuity of 20/25 (+0.10 logMAR) or better in each eye
  • Willingness to wear the lenses for a minimum of 10 hours/day, at least six days a week for the duration of the study

Exclusion Criteria:

  • Subjects receiving myopia control treatments within the past six months
  • History of premature (less than 3.3 lb) or preterm birth (earlier than 30 weeks)
  • Current history of using systemic or ocular medications (including artificial tears) that may affect contact lens wear, tear film health, refractive state, pupillary response or accommodative function
  • History of ocular or systemic diseases, including those that may affect refractive development
  • Known allergy to fluorescein, benoxinate, proparacaine, or tropicamide
  • Contact lens contraindications (e.g., giant papillary keratoconjunctivitis)
  • Corneal disorders (e.g., hypoesthesia, keratoconus)
  • Strabismus at distance or near with distance glasses or contact lenses
  • Subjects exhibiting poor personal hygiene that may affect the compliance of contact lens wear.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

Children who are randomized to this group will wear one type of daily use, daily disposable, single-vision soft contact lens for at least four hours starting in the afternoon (after school) and another type of daily use, daily disposable, single-vision soft contact lens for the remainder of the time daily for one year.

sham comparator: Control group

Children who are randomized to this group will wear daily use, daily disposable, single-vision soft contact lenses full time for one year. Contact lenses will be worn for a minimum of 10 hours per day.

Interventions

Specialized soft contact lens 1

These are daily-wear, daily-replacement lenses. They are identical to specialized soft contact lens 2 in material, comfort, and lens geometry. They differ only in their spectral profile.

Specialized soft contact lens 2

These are daily-wear, daily-replacement lenses. They are identical to specialized soft contact lens 1 in material, comfort, and lens geometry. They differ only in their spectral profile.

Primary outcome measure

  • Change in cycloplegic spherical equivalent refractive error [ Time Frame: Baseline and 12 months ]
  • Change in axial length [ Time Frame: Baseline and 12 months ]

Central Contacts and Locations

Central contacts

Sindhu Gurrala, MPH

205.975.3881sgurral2@uab.edu

Locations

University of Alabama at Birmingham School of Optometry

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Safal Khanal, OD, PhD

205.934.4558skhanal@uab.edu

Sindhu Gurrala, MPH

205.975.3881sgurral2@uab.edu

Principal Investigator:

Safal Khanal, OD, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Keywords

  • Childhood Myopia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-10-08.