CompletedNot Applicable

Comparison of Two Contact Lens Designs

United States30 participantsStarted 2025-05-22

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Computer vision syndrome questionnaire (CVS-Q)

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

Trial details

NCT IDNCT07488208

SponsorSouthern College of Optometry

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-02

View on ClinicalTrials.gov More Computer Vision Syndrome trials