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

NCT05949697 | Completed

• 1 other identifier: MW230012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Keywords

Eye Dryness; Dry Eye Drink

Outcome Measures

Primary Outcomes (1)

• Change on the SPEED score

  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

  Day 0 and Day 30

Secondary Outcomes (2)

• Change in Tear Osmolarity

  Day 0 and Day 30

• Change in MMP-9 levels

  Day 0 and Day 30

Study Arms (1)

Dry Eye Drink

OTHER

Dietary Supplement: Dry Eye Drink

Interventions

Dry Eye Drink DIETARY_SUPPLEMENT

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

Dry Eye Drink

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bruder Healthcare: lead
• CBCC Global Research: collaborator

Study Sites (1)

CBCC Global Research Site:001

Bakersfield, California, 93308, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Xerophthalmia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Conjunctival Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: August 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (1)