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

Primary Purpose

Dry Eye

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Eye Drink
Sponsored by
Bruder Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dry Eye focused on measuring Eye Dryness, Dry Eye Drink

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CBCC Global Research Site:001

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dry Eye Drink

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2023
Last Updated
July 10, 2023
Sponsor
Bruder Healthcare
Collaborators
CBCC Global Research
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1. Study Identification

Unique Protocol Identification Number
NCT05949697
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bruder Healthcare
Collaborators
CBCC Global Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Eye Dryness, Dry Eye Drink

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry Eye Drink
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
Dry Eye Drink
Intervention Description
Dry Eye Drink is a dietary supplement containing electrolytes, vitamins and natural anti-inflammatories.
Primary Outcome Measure Information:
Title
Change on the SPEED score
Description
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
Time Frame
Day 0 and Day 30
Secondary Outcome Measure Information:
Title
Change in Tear Osmolarity
Description
Change in Tear Osmolarity from Baseline to end of treatment
Time Frame
Day 0 and Day 30
Title
Change in MMP-9 levels
Description
Change in MMP-9 levels from Baseline to end of treatment
Time Frame
Day 0 and Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 ≥ 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harakh Shah
Phone
661-979-5892
Email
harakh.shah@cbcc.global
First Name & Middle Initial & Last Name or Official Title & Degree
Eldho Jose
Email
eldho.jose@cbcc.global
Facility Information:
Facility Name
CBCC Global Research Site:001
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States

12. IPD Sharing Statement

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

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