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Completed

NCT Number: NCT05949697

A Prospective Study of the Dry Eye Drink That Evaluates Hydration and Subject's Assessment on Eye Dryness

A study to assess the effect of the Dry Eye Drink on eye dryness

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CBCC Global Research Site:001

Bakersfield, California, 93308, United States

About this study

This is a prospective, non-randomized, comparative study of the Dry Eye Drink by Bruder Healthcare that evaluates hydration and subject's assessment on eye dryness. Subjects will administer the Dry Eye Drink by adding one sachet of the Dry Eye Drink powder in 12 Oz of water.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
  • Subjects with symptomatic Dry Eye Syndrome confirmed at baseline in at least any one or both the eyes.
  • Subjects with ≥ 310 mOsmol/L tear osmolarity.
  • Subjects with ≥ 6 SPEED score.
  • Subject willing to provide written informed consent and able to comply with protocol requirements.

Exclusion criteria

  • Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
  • Have undergone mechanical treatment for meibomian gland dysfunction using thermal pulsation/expression (e.g., LipiFlow) or intense pulsed light (e.g., OptiLight) therapy within 6 months prior to the Screening/Baseline Visit
  • Have a known hypersensitivity to any of the study product components
  • Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
  • Have evidence of clinically significant ocular trauma
  • Have active ocular Herpes simplex or Herpes Zoster infection
  • Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
  • Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
  • Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
  • Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
  • Have an ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity)
  • Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
  • Participation in any clinical study within 30 days before the first administration of study product.
  • Subjects who are illiterate and cannot complete the subject diary independently.

Treatment and study plan

Dry Eye Drink

Dietary Supplement

Dry Eye Drink is a dietary supplement containing electrolytes, vitamins and natural anti-inflammatories.

Primary outcomes

  1. Change on the SPEED score

    Time frame: Day 0 and Day 30

    Change on the subjects' perception of eye dryness from Baseline to end of treatment as assessed by Standard Patient Evaluation of Eye Dryness (SPEED) score

Secondary outcomes

  1. Change in Tear Osmolarity

    Time frame: Day 0 and Day 30

    Change in Tear Osmolarity from Baseline to end of treatment

  2. Change in MMP-9 levels

    Time frame: Day 0 and Day 30

    Change in MMP-9 levels from Baseline to end of treatment

Sponsors and collaborators

Lead sponsor

Bruder Healthcare

Industry

Collaborators

  • CBCC Global Research

Registry information

Official study title

A Prospective Study of the Dry Eye Drink by Bruder Healthcare That Evaluates Hydration and Subject's Assessment on Eye Dryness

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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