Dry Eye Disease (DED)Phase 2NCT07078955
A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease
A Phase 2 study testing BRM421 Ophthalmic Solution, 0.03%, Artificial Tear and BRM421 Ophthalmic Solution, 0.06% in people with Dry Eye Disease (DED) and Keratoconjunctivitis Sicca, run by BRIM Biotechnology Inc. at 1 site in Taiwan.
Trial summary
To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED), Keratoconjunctivitis Sicca
- What is being tested?
- BRM421 Ophthalmic Solution, 0.03%, Artificial Tear and BRM421 Ophthalmic Solution, 0.06%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are ≥18 years of age;
- Are willing and able to comply with all study procedures and restrictions and the visit schedule;
- Have a self-reported history of dry eye prior to enrollment;
- If a woman of childbearing potential (WOCBP): are non-lactating, have a negative urine pregnancy test (UPT), and agree to use an acceptable form of contraception for the duration of the study;
Who cannot join
- Within 3 months prior to Visit 1, have participated in any other investigational study or used an investigational product or device;
- Have any history of organ or bone marrow transplant, immunodeficiency disorder, human immunodeficiency virus, or hepatitis C, or any evidence of acute active hepatitis A (anti-hepatitis A virus immunoglobulin M);
- Have any significant illness or condition that, in the opinion of the Investigator, could affect the study outcome measures. Such illnesses include (but are not limited to) Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, severe cardiopulmonary disease, poorly controlled hypertension or diabetes, or drug/alcohol addiction;
- Within 12 months prior to Visit 1, have undergone any ocular surgical procedure, including laser-assisted in situ keratomileusis (LASIK) or a similar corneal refractive surgery;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
New Taipei Municipal TuCheng Hospital
New Taipei City
Ning Alin Associate Director, +886-2-26598586, alin.ning@brimbiotech.com
About this study
Official title: A Phase 2, Multicenter, Randomized, Open-Labeled, Artificial Tear-Controlled, 6-Week Clinical Study to Assess the Dose Regimen, Safety and Efficacy of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease
To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED)
- Conditions
- Dry Eye Disease (DED), Keratoconjunctivitis Sicca
- Being tested
- BRM421 Ophthalmic Solution, 0.03%, Artificial Tear, BRM421 Ophthalmic Solution, 0.06%
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRM421 Ophthalmic Solution, 0.03%Drug
A topical drop of 0.03% BRM421 ophthalmic solution.
Artificial TearDrug
A topical drop of Artificial Tear.
BRM421 Ophthalmic Solution, 0.06%Drug
A topical drop of 0.06% BRM421 ophthalmic solution.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Tear | Other | Not described Receives: Drug: Artificial Tear |
| BRM421 Ophthalmic Solution, 0.03% | Active comparator | Not described Receives: Drug: BRM421 Ophthalmic Solution, 0.03% |
| BRM421 Ophthalmic Solution, 0.06% | Active comparator | Not described Receives: Drug: BRM421 Ophthalmic Solution, 0.06% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total corneal fluorescein staining (tCFS) score
Total corneal fluorescein staining (tCFS) score by using NEI Scale (0-20, higher scores mean a worse outcome)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startDec 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BRIM Biotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078955
- Sponsor's protocol ID
- BRM421-24-C001
- Status last verified
- Oct 2025
- First submitted
- 14 Jul 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Open-Labeled, Artificial Tear-Controlled, 6-Week Clinical Study to Assess the Dose Regimen, Safety and Efficacy of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07078955
- Acronym / sponsor ID
- BRM421-24-C001
- Conditions
- Dry Eye Disease (DED), Keratoconjunctivitis Sicca
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- BRIM Biotechnology Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Jul 2025 (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.
To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Artificial Tear | Other | Drug: Artificial Tear |
| BRM421 Ophthalmic Solution, 0.03% | Active comparator | Drug: BRM421 Ophthalmic Solution, 0.03% |
| BRM421 Ophthalmic Solution, 0.06% | Active comparator | Drug: BRM421 Ophthalmic Solution, 0.06% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are ≥18 years of age;
- Are willing and able to comply with all study procedures and restrictions and the visit schedule;
- Have a self-reported history of dry eye prior to enrollment;
- If a woman of childbearing potential (WOCBP): are non-lactating, have a negative urine pregnancy test (UPT), and agree to use an acceptable form of contraception for the duration of the study;
Key exclusion criteria (4 listed)
- Within 3 months prior to Visit 1, have participated in any other investigational study or used an investigational product or device;
- Have any history of organ or bone marrow transplant, immunodeficiency disorder, human immunodeficiency virus, or hepatitis C, or any evidence of acute active hepatitis A (anti-hepatitis A virus immunoglobulin M);
- Have any significant illness or condition that, in the opinion of the Investigator, could affect the study outcome measures. Such illnesses include (but are not limited to) Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, severe cardiopulmonary disease, poorly controlled hypertension or diabetes, or drug/alcohol addiction;
- Within 12 months prior to Visit 1, have undergone any ocular surgical procedure, including laser-assisted in situ keratomileusis (LASIK) or a similar corneal refractive surgery;
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 |
|---|---|---|
| BRM421 Ophthalmic Solution, 0.03%A topical drop of 0.03% BRM421 ophthalmic solution. | Drug | BRM421 Ophthalmic Solution, 0.03% |
| Artificial TearA topical drop of Artificial Tear. | Drug | Artificial Tear |
| BRM421 Ophthalmic Solution, 0.06%A topical drop of 0.06% BRM421 ophthalmic solution. | Drug | BRM421 Ophthalmic Solution, 0.06% |
Primary outcome
Change from baseline in total corneal fluorescein staining (tCFS) score
Time frame: 6 weeks
Total corneal fluorescein staining (tCFS) score by using NEI Scale (0-20, higher scores mean a worse outcome)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BRM421 Ophthalmic Solution, 0.03%, Artificial Tear and BRM421 Ophthalmic Solution, 0.06% in people with Dry Eye Disease (DED) and Keratoconjunctivitis Sicca, run by BRIM Biotechnology Inc. at 1 site in Taiwan.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Oct 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Alin Associate Director (+886-2-26598586, alin.ning@brimbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total corneal fluorescein staining (tCFS) score (time frame: 6 weeks). 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 20 Oct 2025.