NCT07488208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 12, 2026

Last Update Submit

March 20, 2026

Conditions

Computer Vision SyndromeAccommodation

Keywords

computer vision syndromecontact lens

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

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

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

  • Subjective assessment of accommodation

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

  • Objective assessment of accommodation

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

Study Arms (2)

Initial assignment to MyDay

OTHER

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

Initial assignment to MyDay Energys

OTHER

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

Interventions

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.

Initial assignment to MyDayInitial assignment to MyDay Energys

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Related Publications (10)

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

    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.

    PMID: 39553617BACKGROUND

  • 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.

    PMID: 21336227BACKGROUND

  • 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.

    PMID: 32201056BACKGROUND

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

    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.

    PMID: 35809192BACKGROUND

  • 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.

    PMID: 21480937BACKGROUND

  • 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.

    PMID: 39308959BACKGROUND

  • 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.

    PMID: 29963645BACKGROUND

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

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 23, 2026

Study Start

May 22, 2025

Primary Completion

September 2, 2025

Study Completion

September 2, 2025

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Starting from 6 monthes of publication upto 24 months after publications.
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.

Locations

US(1)