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

NCT05481450 | Completed DMC

• 1 other identifier: OA051022
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Schirmer's Test (without anesthesia)

  Change from Baseline in the length of wetting on a sterile Schirmer's Test strip. Without previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. The patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)

  Baseline, Day 14, Day 28, Day 56

• Ocular Surface Disease Index (OSDI) score

  Change from Baseline in Ocular Surface Disease Index score. The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.

  Baseline, Day 14, Day 28, Day 56

Secondary Outcomes (6)

• Tear Film Break-Up Time (TBUT)

  Baseline, Day 14, Day 28, Day 56

• Standard Patient Evaluation of Eye Dryness (SPEED) score

  Baseline, Day 14, Day 28, Day 56

• Corneal and Conjunctival Staining

  Baseline, Day 56

• Tear Osmolarity

  Baseline, Day 56

• MMP-9

  Baseline, Day 56

Other Outcomes (38)

• Changes in White Blood Cell count

  Baseline, Day 56

• Changes in Red Blood Cell count

  Baseline, Day 56

• Changes in Hemoglobin levels

  Baseline, Day 56

Study Arms (2)

Dietary supplement

EXPERIMENTAL

Consume one capsule every morning after the breakfast at the same time every day for 56 days

Dietary Supplement: Nutritears®

Placebo

PLACEBO COMPARATOR

Consume one capsule every morning after the breakfast at the same time every day for 56 days

Dietary Supplement: Placebo

Interventions

Nutritears® DIETARY_SUPPLEMENT

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

Dietary supplement

Placebo DIETARY_SUPPLEMENT

Soybean oil capsule (Total capsule weight ≈670 mg)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Applied Science & Performance Institute: lead
• True Eye Experts - New Tampa: collaborator
• True Eye Experts - Lutz: collaborator
• True Eye Experts - South Tampa: collaborator

Study Sites (3)

True Eye Experts - Lutz

Lutz, Florida, 33549, United States

Location

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

True Eye Experts - New Tampa

Tampa, Florida, 33647, United States

Location

Related Publications (1)

• Gioia N, Gerson J, Ryan R, Barbour K, Poteet J, Jennings B, Sharp M, Lowery R, Wilson J, Morde A, Rai D, Padigaru M, Periman LM. A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial. Front Ophthalmol (Lausanne). 2024 Apr 24;4:1362113. doi: 10.3389/fopht.2024.1362113. eCollection 2024.

  PMID: 38984118 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: August 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 22, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-03

Locations

US (3)