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Computer Vision SyndromeNCT07488208

Comparison of Two Contact Lens Designs

A study testing Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens in people with Computer Vision Syndrome and Accommodation, run by Southern College of Optometry at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Computer Vision Syndrome, Accommodation
What is being tested?
Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
22 May 2025to 2 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southern College of Optometry

    Memphis, Tennessee, 38104

Other trials in United States

About this study

Official title: 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.
Read the 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.

Being tested
Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens
Keywords
computer vision syndrome, contact lens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT07488208
Study groupRoleWhat they receive
Initial assignment to MyDayOtherSubject assigned to MyDay contact lens then crossed over to MyDay Energys
Receives: Device: Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens
Initial assignment to MyDay EnergysOtherSubject assigned to MyDay Energys contact lens then crossed over to MyDay contact lens.
Receives: Device: Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Computer vision syndrome questionnaire (CVS-Q)

    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.

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

Secondary outcomes (3)

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

    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.

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

  2. Subjective assessment of accommodation

    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.

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

  3. Objective assessment of accommodation

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start22 May 2025
  3. Primary completion2 Sep 2025
  4. Study completion2 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07488208
Sponsor's protocol ID
SCO IRB00006733
Status last verified
Mar 2026
First submitted
12 Mar 2026
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All IPD that underlie results in a publication will be shared upon request by qualified independent researchers.

Publications

  • Digital Eye Strain. https://coopervision.com/sites/coopervision.com/files/media-document/digital-eye-strain-research-report.pdf (2024).

  • Buch JR, Martin P, Xu J. Comfort advantages demonstrated with a novel soft contact lens: A randomized clinical trial. Heliyon. 2024 Oct 30;10(21):e39995. doi: 10.1016/j.heliyon.2024.e39995. eCollection 2024 Nov 15.

    PubMed 39553617

  • Pitt WG, Jack DR, Zhao Y, Nelson JL, Pruitt JD. Loading and release of a phospholipid from contact lenses. Optom Vis Sci. 2011 Apr;88(4):502-6. doi: 10.1097/OPX.0b013e31820e9ff8.

    PubMed 21336227

  • Kajita M, Muraoka T, Orsborn G. Changes in accommodative micro-fluctuations after wearing contact lenses of different optical designs. Cont Lens Anterior Eye. 2020 Oct;43(5):493-496. doi: 10.1016/j.clae.2020.03.003. Epub 2020 Mar 19.

    PubMed 32201056

  • Bishop, M., Ruston, D. & Buch, J. Technologies of MAX Contact Lenses Address a Lifetime of Needs. Review of Presbyopia and the Aging Eye (2023)

  • Kaur K, Gurnani B, Nayak S, Deori N, Kaur S, Jethani J, Singh D, Agarkar S, Hussaindeen JR, Sukhija J, Mishra D. Digital Eye Strain- A Comprehensive Review. Ophthalmol Ther. 2022 Oct;11(5):1655-1680. doi: 10.1007/s40123-022-00540-9. Epub 2022 Jul 9.

    PubMed 35809192

  • Rosenfield M. Computer vision syndrome: a review of ocular causes and potential treatments. Ophthalmic Physiol Opt. 2011 Sep;31(5):502-15. doi: 10.1111/j.1475-1313.2011.00834.x. Epub 2011 Apr 12.

    PubMed 21480937

  • Pucker AD, Kerr AM, Sanderson J, Lievens C. Digital Eye Strain: Updated Perspectives. Clin Optom (Auckl). 2024 Sep 18;16:233-246. doi: 10.2147/OPTO.S412382. eCollection 2024.

    PubMed 39308959

  • Sheppard AL, Wolffsohn JS. Digital eye strain: prevalence, measurement and amelioration. BMJ Open Ophthalmol. 2018 Apr 16;3(1):e000146. doi: 10.1136/bmjophth-2018-000146. eCollection 2018.

    PubMed 29963645

  • Backlinko Team. Revealing Average Screen Time Statistics. https://backlinko.com/screen-time-statistics (2025).

Questions about this trial

What is this clinical trial studying?

A study testing Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens in people with Computer Vision Syndrome and Accommodation, run by Southern College of Optometry at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Computer vision syndrome questionnaire (CVS-Q) (time frame: Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07488208, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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