Efficacy and Safety Safety of Nutritears® in Adults With Dry Eye Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Dry Eye, Dry Eye Syndromes

In brief

This is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES). Subjects shall be instructed to consume one capsule of their assigned investigational study product every morning after the breakfast, at the same time every day, for 56 days (8 weeks).

Key facts

Study ID

NCT05481450

Run by

Applied Science & Performance Institute

People needed

131

Starts

2022-08-15

Expected to finish

2023-05-22

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
• 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.
• 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.
• 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
• 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.
• Subject willing to provide written consent.
• 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.

You may not qualify if…

• Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
• History of allergy or sensitivity to Lutein, Zeaxanthin, Curcumin or Vitamin D3, related compounds or any component of the formulation.
• 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).
• 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.
• Subject with poorly controlled diabetes mellitus, rheumatoid arthritis and Systemic Lupus Erythematosus (SLE) which causes Dry Eye Syndrome.
• Subjects with herpetic eye disease.
• Subjects with chronic infection of the lacrimal gland.
• Subjects with Laser In Situ Keratomileusis (LASIK).
• Subjects with poorly controlled hypertension (>140/96 mm of Hg).
• Subjects with evidence of malignancy.
• Subjects suffering from major systemic illness necessitating long term drug treatment (Psychological, Neurological, Endocrinal, Cardiovascular disorders, etc.).
• 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.
• 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
• Subjects with inability to swallow soft gel capsules.
• Use of lutein, zeaxanthin, curcumin, or vitamin D3 on prescription for other medical indications or for health-conscious reasons
• Use of steroids or hormone replacement therapy or any other medication that may adversely affect the outcome of the study.
• Subjects on aspirin or anti-coagulant therapy.
• Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.

Where it is running

• True Eye Experts - Lutz — Lutz, Florida, United States
• Applied Science and Performance Institute — Tampa, Florida, United States
• True Eye Experts - New Tampa — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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