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Supplement shows promise for dry eye sufferers in new study

NCT ID NCT05481450

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a dietary supplement called Nutritears, containing lutein, zeaxanthin, curcuminoids, and vitamin D3, can improve dry eye symptoms. 131 adults with dry eye syndrome took either the supplement or a placebo daily for 8 weeks. Researchers measured tear production and symptom scores to see if the supplement made a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nutritears (a dietary supplement containing lutein/zeaxanthin, curcuminoids, and vitamin D3)
What this could lead to
If it works, this could point toward a simple, over-the-counter supplement to ease dry eye symptoms and improve tear production.
What could go wrong
This is a small, completed trial with 131 people. The supplement may not work better than a placebo, and results may not apply to everyone with dry eye.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

131 people

The number who actually took part.

Started

Aug 2022

Finished

May 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and/or female subjects aged between 18 and 65 years (both limits inclusive). 2. Clinical diagnosis of symptomatic Dry Eye Syndrome confirmed by a licensed optometrist at Baseline by presence of irritation, foreign body (sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort and altered/effected QoL at least in any one of the eyes. 3. Subjects shall be in good health and free from any clinically significant disease, other than Dry Eye Syndrome (DES), that might interfere with the study evaluations. 4. Subjects must meet the following criteria in at least one eye, as determined by a licensed optometrist: i. Schirmer's Test without anesthesia ≤ 10 mm ii. Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40 5. Subjects with any of the following in at least one eye, as determined by a licensed optometrist: i. Tear film break up time ≤ 10 seconds ii. Tear Osmolarity ≥ 316 milliosmole /L iii. Fluorescein corneal staining ≥ 1 and \< 3. 6. Subject willing to provide written consent. 7. Subjects shall be willing and able to understand and comply with the requirements of the study, administer the study product as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study. Exclusion Criteria: 1. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 2. History of allergy or sensitivity to Lutein, Zeaxanthin, Curcumin or Vitamin D3, related compounds or any component of the formulation. 3. Presence of severe dry eye syndrome with complications such as perforated Corneal Ulcer, Uveitis and Glaucoma, in the Investigator's opinion that may interfere with the evaluation of the Subject's Dry Eye Syndrome (DES). 4. Current evidence of ocular infections or inflammatory conditions like acute conjunctivitis or other medical condition that, in the Investigator's opinion, would place the Subject at undue risk by participating or compromise the integrity of the study data. 5. Subject with poorly controlled diabetes mellitus, rheumatoid arthritis and Systemic Lupus Erythematosus (SLE) which causes Dry Eye Syndrome. 6. Subjects with herpetic eye disease. 7. Subjects with chronic infection of the lacrimal gland. 8. Subjects with Laser In Situ Keratomileusis (LASIK). 9. Subjects with poorly controlled hypertension (\>140/96 mm of Hg). 10. Subjects with evidence of malignancy. 11. Subjects suffering from major systemic illness necessitating long term drug treatment (Psychological, Neurological, Endocrinal, Cardiovascular disorders, etc.). 12. Subjects with concurrent serious Hepatic Dysfunction or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and Chronic Obstructive Pulmonary Disease (COPD) Subjects) or other concurrent severe disease. 13. Any ocular trauma or surgery that may affect corneal sensitivity and/or normal tear distribution (e.g., cataract surgery, refractive surgery) within the 6 previous months to study inclusion 14. Subjects with inability to swallow soft gel capsules. 15. Use of lutein, zeaxanthin, curcumin, or vitamin D3 on prescription for other medical indications or for health-conscious reasons 16. Use of steroids or hormone replacement therapy or any other medication that may adversely affect the outcome of the study. 17. Subjects on aspirin or anti-coagulant therapy. 18. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Applied Science and Performance Institute

    Tampa, Florida, 33607, United States

  • True Eye Experts - Lutz

    Lutz, Florida, 33549, United States

  • True Eye Experts - New Tampa

    Tampa, Florida, 33647, United States

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