NCT07488208

Comparison of Two Contact Lens Designs

Crossover Comparison of Two Novel Stenfilcon A Contact Lens Designs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Southern College of Optometry · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The proposed study will address this gap by comparing the efficacy of two novel stenfilcon A contact lens designs in alleviating accommodative burden associated with digital device usage. The primary outcomes are measured with the following: * Computer vision syndrome questionnaire * Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm. * Binocular range of clear vision * Subjective assessment of accommodation * Objective assessment of accommodation Subjects will be randomly assigned to wear one contact lens design for 5 days. Then crossed over tot he opposing design after a three day washout period, and again asked to wear the lens for 5 days.

Detailed description

Digital device use is associated with symptoms known as Computer Vision Syndrome (CVS), which may include eye strain, dryness, blurred vision, and headaches. Contact lens wearers may experience increased symptoms during prolonged near-focus activities. New contact lens designs have been developed to help reduce accommodative stress during digital device use; however, clinical evidence comparing their performance remains limited. This randomized, double-masked, crossover study will compare two daily disposable stenfilcon A contact lenses. Each participant will wear both lens designs for five days each, separated by a three-day washout. Primary outcomes include subjective symptoms, visual acuity, range of clear vision, subjective accommodative performance, and objective accommodative response. The study is designed to provide evidence regarding the relative performance of the two lens designs in reducing visual discomfort and accommodative burden during digital device use.

Conditions

• Computer Vision Syndrome
• Accommodation

Interventions

Type	Name	Description
DEVICE	Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens	The MyDay stenfilcon A contact lens is a spherical lens. The MyDay Energys stenfilcon A contact lens has Digital Boost technology that incorporate 0.3D ADD power into the lens.

Timeline

• Start date: 2025-05-22
• Primary completion: 2025-09-02
• Completion: 2025-09-02
• First posted: 2026-03-23
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study