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OpenTrials
Completed

NCT Number: NCT07488208

Comparison of Two Contact Lens Designs

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.

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Key information

Conditions

Computer Vision Syndrome Accommodation

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Score of >6 on CVS-Q
  • Male or female
  • Age >18 years to 35 years of age
  • Experienced, well-adapted contact lens wearers
  • Spherical equivalent refractive error between ±6.00DS with astigmatism < -0.75D
  • Normal stereopsis and binocular status

Exclusion criteria

  • Monovision
  • History of refractive surgery
  • Binocular vision abnormalities
  • Current ocular or systemic disease that may affect the eye
  • Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.

Treatment and study plan

Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens

Device

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.

Primary outcomes

  1. Computer vision syndrome questionnaire (CVS-Q)

    Time frame: Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)

    Computer vision syndrome questionnaire (CVS-Q) is a reliable and valid tool for measuring visual symptoms related to computer use in the workplace. It asks subjects to rate the frequency (never, occasionally, often) and intensity (moderate, intense) of 16 visual symptoms.

Secondary outcomes

  1. Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm

    Time frame: Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)

    Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm. The M&S Technologies Smart System II (M&S Technologies, Niles, IL) has been shown to be comparable to ETDRS and Pelli Robson charts. Computer tests have been shown to a reliable, capable way of assessing vision.

  2. Subjective assessment of accommodation

    Time frame: Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)

    Subjective assessment of accommodation is assessed by plotting a binocular defocus curve over-refraction at 6M (-3.00 to +3.00D in 0.50D steps) in phoropter while wearing contact lenses. Room luminance will be controlled and subjects will view optotypes through a standardized 4 mm aperture to reduce confounding effects on retinal defocus. Lenses will be presented in a randomized order.

  3. Objective assessment of accommodation

    Time frame: Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)

    Objective assessment of accommodation Multiple studies support quantitative and qualitative changes in accommodation may be associated with asthenopia. The Grand Seiko WR 5500 (AIT, Bensenville, IL) has been shown to be capable of reliably measuring objective accommodation. A near target is viewed through increasing powered negative trial lenses (0 diopter to -4.00 diopter in 1.00D steps) and the response measured with the WR-5500K.

Sponsors and collaborators

Lead sponsor

Southern College of Optometry

Other

Registry information

Official study title

Crossover Comparison of Two Novel Stenfilcon A Contact Lens Designs

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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