Clinical trial NCT05949697: A Prospective Study of the Dry Eye Drink That Evaluates Hydration and Subject's Assessment on Eye Dryness
Official title: A Prospective Study of the Dry Eye Drink by Bruder Healthcare That Evaluates Hydration and Subject's Assessment on Eye Dryness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Eye Dryness
Dry Eye Drink
Lead sponsor: Bruder Healthcare
Sponsor class: INDUSTRY
Collaborators: name: CBCC Global Research
First posted: 2023-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change on the SPEED score
timeFrame: Day 0 and Day 30
Secondary outcomes:
measure: Change in Tear Osmolarity
timeFrame: Day 0 and Day 30
measure: Change in MMP-9 levels
timeFrame: Day 0 and Day 30
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: CBCC Global Research Site:001
state: California
Study officials:
References: