Comparison of Two Contact Lens Designs

March 20, 2026 updated by: Yueren Wang, OD, Southern College of Optometry

Crossover Comparison of Two Novel Stenfilcon A 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Southern College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Initial assignment to MyDay
Subject assigned to MyDay contact lens then crossed over to MyDay Energys
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.
Other: Initial assignment to MyDay Energys
Subject assigned to MyDay Energys contact lens then crossed over to MyDay contact lens.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)
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.
Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)
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.
Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern College of Optometry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Actual)

September 2, 2025

Study Completion (Actual)

September 2, 2025

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCO IRB00006733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be shared upon request by qualified independent researchers.

IPD Sharing Time Frame

Starting from 6 monthes of publication upto 24 months after publications.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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