Efficacy and Safety Safety of Nutritears® in Adults With Dry Eye Syndrome
Condition: Dry Eye; Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Nutritears®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Strength: Lutein/Zeaxanthin - 20/4 mg; Curcuminoids 200 mg; Vitamin D3 600 IU (Total capsule weight ≈670 mg); Soybean oil capsule (Total capsule weight ≈670 mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment