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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial assignment to MyDay | Other | Subject assigned to MyDay contact lens then crossed over to MyDay Energys |
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| Initial assignment to MyDay Energys | Other | Subject assigned to MyDay Energys contact lens then crossed over to MyDay contact lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Digital Eye Strain. https://coopervision.com/sites/coopervision.com/files/media-document/digital-eye-strain-research-report.pdf (2024). | ||
| 39553617 | Background | 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. | |
| 21336227 |
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All IPD that underlie results in a publication will be shared upon request by qualified independent researchers.
Starting from 6 monthes of publication upto 24 months after publications.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 9, 2025 | Mar 12, 2026 | Prot_SAP_ICF_000.pdf |
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| 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. | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) |
| 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. | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) |
| Background |
| 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. |
| 32201056 | Background | 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. |
| Background | Bishop, M., Ruston, D. & Buch, J. Technologies of MAX Contact Lenses Address a Lifetime of Needs. Review of Presbyopia and the Aging Eye (2023) |
| 35809192 | Background | 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. |
| 21480937 | Background | 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. |
| 39308959 | Background | 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. |
| 29963645 | Background | 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. |
| Background | Backlinko Team. Revealing Average Screen Time Statistics. https://backlinko.com/screen-time-statistics (2025). |