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

NCT05481450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2023-05-26

No results posted yet for this study

Summary

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).

Conditions

  • Dry Eye
  • Dry Eye Syndromes

Interventions

DIETARY_SUPPLEMENT

Nutritears®

Strength: Lutein/Zeaxanthin - 20/4 mg; Curcuminoids 200 mg; Vitamin D3 600 IU (Total capsule weight ≈670 mg)

DIETARY_SUPPLEMENT

Placebo

Soybean oil capsule (Total capsule weight ≈670 mg)

Sponsors & Collaborators

  • True Eye Experts - New Tampa

    collaborator UNKNOWN
  • True Eye Experts - Lutz

    collaborator UNKNOWN
  • True Eye Experts - South Tampa

    collaborator UNKNOWN
  • Applied Science & Performance Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2023-05-15
Completion
2023-05-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481450 on ClinicalTrials.gov