Dry EyeNCT05949697
A Prospective Study of the Dry Eye Drink That Evaluates Hydration and Subject's Assessment on Eye Dryness
A study testing Dry Eye Drink in people with Dry Eye, run by Bruder Healthcare at 1 site in United States.
Trial summary
A study to assess the effect of the Dry Eye Drink on eye dryness Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Dry Eye Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
CBCC Global Research Site:001
Bakersfield, California, 93308
About this study
Official title: A Prospective Study of the Dry Eye Drink by Bruder Healthcare That Evaluates Hydration and Subject's Assessment on Eye Dryness
A study to assess the effect of the Dry Eye Drink on eye dryness
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Dry Eye Drink
- Keywords
- Eye Dryness, Dry Eye Drink
- Medical subject headings
- Dry Eye Syndromes, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Eye DrinkDietary supplement
Dry Eye Drink is a dietary supplement containing electrolytes, vitamins and natural anti-inflammatories.
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Drink | Other | Not described Receives: Dietary Supplement: Dry Eye Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 and Day 30
Secondary outcomes (2)
Change in Tear Osmolarity
Change in Tear Osmolarity from Baseline to end of treatment
Measured: Day 0 and Day 30
Change in MMP-9 levels
Change in MMP-9 levels from Baseline to end of treatment
Measured: Day 0 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Aug 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruder Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949697
- Sponsor's protocol ID
- MW230012
- Status last verified
- Mar 2025
- First submitted
- 10 Jul 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Dry Eye Drink by Bruder Healthcare That Evaluates Hydration and Subject's Assessment on Eye Dryness
- ClinicalTrials.gov ID
- NCT05949697
- Acronym / sponsor ID
- MW230012
- Conditions
- Dry Eye
- Keywords
- Eye Dryness, Dry Eye Drink
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bruder HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Drink | Other | Dietary Supplement: Dry Eye Drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Eye DrinkDry Eye Drink is a dietary supplement containing electrolytes, vitamins and natural anti-inflammatories. | Dietary supplement | Dry Eye Drink |
Primary outcome
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
2 secondary outcomes
Change in Tear Osmolarity
Time frame: Day 0 and Day 30
Change in MMP-9 levels
Time frame: Day 0 and Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Eye Drink in people with Dry Eye, run by Bruder Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the SPEED score (time frame: Day 0 and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.