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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05949697
• Other study ID #: MW230012
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: Bruder Healthcare
• Contact: Harakh Shah
• Phone: 661-979-5892
• Email: harakh.shah[@]cbcc.global
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 = 320 mOsmol/L tear osmolarity.

• Subjects with positive result for MMP-9 as assessed by Quidel's test.

• 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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	CBCC Global Research Site:001	Bakersfield	California

Sponsors (2)

Lead Sponsor	Collaborator
Bruder Healthcare	CBCC Global Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Tear Osmolarity	Change in Tear Osmolarity from Baseline to end of treatment	Day 0 and Day 30
Secondary	Change in MMP-9 levels	Change in MMP-9 levels from Baseline to end of treatment	Day 0 and Day 30