WithdrawnNot Applicable

Treatment of Dry Eye With Supplements

Austria0Started 2011-07

Plain-language summary

Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response on the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface. In addition, an intact tear film is important to provide a smooth optical surface, to act as a barrier to pathogens, to nourish the epithelial cells of the ocular surface and to prevent exsiccation. Alterations in the tear film composition, which can have their origin in several conditions, lead to tear film hyperosmolarity or instability resulting in DES. Regardless of the cause of DES, chronic dryness of the ocular surface leads to an increased susceptibility to oxidative stress, which is triggered by reactive oxygen species (ROS). This results in cell damage and activation of the immune system, keeping up inflammatory processes . In order to prevent ROS damage, several micronutrients such as vitamin C, E, and certain carotenoids, omega-3 free fatty acids, flavonoids and minerals have been used because of their antioxidant capacities. Based on this knowledge the potential of these antioxidant dietary supplements has been discussed as a treatment option for DES. Preliminary data support the hypothesis that antioxidant supplementations, in particular, supplementation with omega 3 fatty acids may be beneficial for patients with DES. The purpose of the present study is to test the hypothesis that treatment with dietary supplements improves subjective and objective symptoms of DES.

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: * Men and women aged over 18 years * History of dry eye syndrome for at least 3 months * Tear Break Up Time (BUT) \< 10 seconds or Schirmer I test \< 7 mm * At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) * -Normal ophthalmic findings except dry eye syndrome Exclusion Criteria: * Participation in a clinical trial in the 3 weeks preceding the study * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator * Wearing of contact lenses * Intake of dietary supplements in the 3 months preceding the study * Glaucoma * Treatment with corticosteroids in the 4 weeks preceding the study * Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study * Ocular infection or inflammation * Ocular surgery in the 3 months preceding the study * Sjögren's syndrome * Stevens-Johnson syndrome * Pregnancy, planned pregnancy or lactating

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

Improvement of subjective symptoms of dry eye syndrome

Timeframe: 12 weeks

Break up time (BUT)

Timeframe: 12 weeks

Trial details

NCT IDNCT01364311

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Dry Eye Syndromes trials