Clinical trial NCT05481450: Efficacy and Safety Safety of Nutritears® in Adults With Dry Eye Syndrome
Official title: A Prospective, Randomized, Double-Blind, Parallel, Placebo-Controlled, Clinical Interventional Study to Evaluate the Efficacy and Safety of Nutritears® in Adult Subjects With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Dry Eye Syndromes
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
Collaborators: name: True Eye Experts - New Tampa
name: True Eye Experts - Lutz
name: True Eye Experts - South Tampa
First posted: 2022-08-01
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study
Primary purpose: TREATMENT

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).

Detailed description: Dry eye syndrome (DES) affects a significant population around the world. Tear film moistens and prevents the ocular surface from dust, toxins, pollutants, etc. An imbalance in any of the tear film layers accompanied by glandular dysfunction leads to DES and it affects the ocular surface. The symptoms include discomfort, visual disturbance, inflammation, damage to ocular surface and tear film instability. 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).

After the informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled in the study. Medical history, including a complete review of all current and past diseases and their respective treatments, will be performed during the screening visit. Physical examination including detailed ocular examination and vital signs (like blood pressure, pulse rate, oxygen saturation and body temperature) will be done during screening. Interviews will be conducted to assess/obtain the medical history, ophthalmic history, systemic disease history, current occupation, exposure to air, presence of allergic problems or concomitant systemic diseases, topical and systemic medications, spectacles/contact lens usage, oral contraceptives, significant history of trauma, chemical burns, drug reactions, history of using any kind of tear substitute, other connective tissue disorder and any history of ocular surgery shall be obtained. Digital screen exposure time from devices like computers, laptops, televisions, tablets, and mobile phones will be recorded.

The following screening tests and procedures shall also be conducted on each potential subject prior to consideration for inclusion into the study:

If the clinical signs and symptoms of DES are present, the following test shall be performed on both the eyes of each subject.

1. Schirmer's Test
2. Ocular Surface Disease Index (OSDI)
3. Tear Film Break-Up Time (TBUT)
4. Standard Patient Evaluation of Eye Dryness (SPEED)
5. Corneal and Conjunctival Staining
6. Tear Osmolarity
7. MMP-9 biomarker

If the subject is eligible as per the inclusion/exclusion criteria then, at Randomization Visit, subjects will be randomly (Double-blind) assigned in 1:1 ratio to one of the two (2) treatment groups i.e., Nutritears® or Placebo at Visit 2.

Subjects will be instructed to consume one capsule every morning after the breakfast, at the same time every day, for 56 consecutive days (8 weeks).

Subjects shall complete five scheduled clinic visits as follows:

* Visit 1: Screening Visit (Day -7 to Day -1) • Visit 2: Randomization Visit (Day 1)
* Visit 3: First Follow-Up Visit (Day 14 ± 3 days)
* Visit 4: Second Follow-Up Visit (Day 28 ± 3 days)
* Visit 5: End of Treatment Visit (Day 56 + 3 days) Total study duration for the clinical part shall be a maximum of 66 days which includes the screening period of 7 days, followed by the treatment period of 56 (8 weeks) and an End of study visit at 56 + 3 days.

Safety assessments include monitoring of adverse events (AEs), physical examination, vital signs (heart rate, blood pressure, oxygen saturation, body temperature) and laboratory assessments. Clinical assessments include the Schirmer's Test, Ocular Surface Disease Index (OSDI), Tear Film Break-Up Time (TBUT), Standard Patient Evaluation of Eye Dryness (SPEED) and Corneal and Conjunctival Staining, Tear Osmolarity and MMP-9 biomarker.

A subject diary shall be provided to the subjects to record the Investigational Product administration details, rescue medication (artificial tears) usage, side effects, and concomitant medication details. All subjects shall be instructed to complete the subject diary after each investigational study product administration. Any additional and missed administrations should also be noted in the subject diary. The daily dosing data shall be used to evaluate compliance. Statistical comparisons for therapeutic efficacy shall be made between Nutritears® to the Placebo product.

Eligibility criteria: 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.

Primary outcomes:
measure: Schirmer's Test (without anesthesia)
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Ocular Surface Disease Index (OSDI) score
timeFrame: Baseline, Day 14, Day 28, Day 56
Secondary outcomes:
measure: Tear Film Break-Up Time (TBUT)
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Standard Patient Evaluation of Eye Dryness (SPEED) score
timeFrame: Baseline, Day 14, Day 28, Day 56
measure: Corneal and Conjunctival Staining
timeFrame: Baseline, Day 56
measure: Tear Osmolarity
timeFrame: Baseline, Day 56
measure: MMP-9
timeFrame: Baseline, Day 56
measure: Rescue Medication Use
timeFrame: Baseline, Day 56
Other outcomes:
measure: Changes in White Blood Cell count
timeFrame: Baseline, Day 56
measure: Changes in Red Blood Cell count
timeFrame: Baseline, Day 56
measure: Changes in Hemoglobin levels
timeFrame: Baseline, Day 56
measure: Changes in Hematocrit levels
timeFrame: Baseline, Day 56
measure: Changes in Mean Corpuscular Volume
timeFrame: Baseline, Day 56
measure: Changes in Mean Corpuscular Hemoglobin
timeFrame: Baseline, Day 56
measure: Changes in Mean Corpuscular Hemoglobin Concentration
timeFrame: Baseline, Day 56
measure: Changes in Red Cell Distribution Width
timeFrame: Baseline, Day 56
measure: Changes in Platelet Count
timeFrame: Baseline, Day 56
measure: Changes in Mean Platelet Volume
timeFrame: Baseline, Day 56
measure: Changes in Granulocyte levels
timeFrame: Baseline, Day 56
measure: Changes in Lymphocytes levels
timeFrame: Baseline, Day 56
measure: Changes in Monocyte levels
timeFrame: Baseline, Day 56
measure: Changes in Eosinophil levels
timeFrame: Baseline, Day 56
measure: Changes in Basophil levels
timeFrame: Baseline, Day 56
measure: Changes in Granulocyte count
timeFrame: Baseline, Day 56
measure: Changes in Lymphocytes count
timeFrame: Baseline, Day 56
measure: Changes in Monocyte count
timeFrame: Baseline, Day 56
measure: Changes in Eosinophil count
timeFrame: Baseline, Day 56
measure: Changes in Basophil count
timeFrame: Baseline, Day 56
measure: Changes in Glucose levels
timeFrame: Baseline, Day 56
measure: Changes in Blood Urea Nitrogen levels
timeFrame: Baseline, Day 56
measure: Changes in Creatinine levels
timeFrame: Baseline, Day 56
measure: Changes in Sodium levels
timeFrame: Baseline, Day 56
measure: Changes in Potassium levels
timeFrame: Baseline, Day 56
measure: Changes in Chloride levels
timeFrame: Baseline, Day 56
measure: Changes in Carbon Dioxide levels
timeFrame: Baseline, Day 56
measure: Changes in Calcium levels
timeFrame: Baseline, Day 56
measure: Changes in Total Protein levels
timeFrame: Baseline, Day 56
measure: Changes in Albumin levels
timeFrame: Baseline, Day 56
measure: Changes in Globulin levels
timeFrame: Baseline, Day 56
measure: Changes in Total Bilirubin levels
timeFrame: Baseline, Day 56
measure: Changes in Alkaline Phosphatase levels
timeFrame: Baseline, Day 56
measure: Changes in Alanine Transaminase levels
timeFrame: Baseline, Day 56
measure: Changes in Aspartate Aminotransferase levels
timeFrame: Baseline, Day 56
measure: Changes in Albumin to Globulin ratio
timeFrame: Baseline, Day 56
measure: Changes in Blood Urea Nitrogen to Creatinine ratio
timeFrame: Baseline, Day 56
measure: Changes in estimated Glomerular Filtration Rate
timeFrame: Baseline, Day 56
Locations:
city: Lutz
country: United States
facility: True Eye Experts - Lutz
state: Florida
city: Tampa
country: United States
facility: Applied Science and Performance Institute
state: Florida
city: Tampa
country: United States
facility: True Eye Experts - New Tampa
state: Florida
Study officials:
References: