Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort (NCT04163328) | Clinical Trial Compass
TerminatedPhase 4
Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
Stopped: COVID disruptions to recruitment and study completion, unforeseen staffing and other issues
United States31 participantsStarted 2022-09-16
Plain-language summary
HydroEye® is a dietary omega 3 fatty acid supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. tested HydroEye® in dry eye patients who were not contact lens wearers and found that symptoms and corneal smoothness improved in response to HydroEye® supplementation. To date, HydroEye® has not been assessed in patients with contact lens discomfort; therefore, the purpose of this clinical trial is to determine the efficacy of HydroEye® as a treatment for contact lens discomfort.
Who can participate
Age range
18 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
. Age ≥18 years
. Provide informed consent and authorization to disclose protected health information
. Willing to follow study protocol
. Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye
. Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5 days per week for the past 30 days
. Have at least a 2-hour difference between overall wear time and comfortable wear time of contact lenses
. Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12)
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
1
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
. Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report
Exclusion criteria
. Meibomian gland dropout ≥75% in either eyelid
. Any changes to the contact lens material, fit, prescription, or care system in the 30 days preceding enrollment or anticipates needing to make changes during the course of the study
. Any systemic disease known to be associated with dry eye
. Any significant ocular surface abnormality that could be associated with ocular surface discomfort, such as ectropion, entropion, trichiasis, infection, severe allergic conjunctivitis, severe eyelid inflammation, etc.
. Any overnight wear of contact lenses or use of daily disposable contact lenses
. Any previous corneal surgery, including all types of corneorefractive surgery
. Have temporary and/or permanent punctal plugs inserted
. Use of supplemental fish oil, or seed oils from borage, evening primrose, sea buckthorn, flaxseed, or black currant within the last 60 days