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BRM421 for Dry Eye Syndrome

Phase 3
Recruiting
Research Sponsored by BRIM Biotechnology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 weeks
Awards & highlights

Study Summary

This trial will compare an experimental dry eye drug to a placebo to see if it is safe and effective.

Who is the study for?
This trial is for adults over 18 with a history of dry eye who have used or are interested in using eye drops. It's not for those with significant eyelid or lash issues, ongoing eye infections, recent contact lens use, women not on birth control, anyone who's used other eye drops within 2 hours before joining, or had LASIK surgery in the past year.Check my eligibility
What is being tested?
The study aims to see if BRM421 Ophthalmic Solution is safe and works better than a placebo (vehicle) at treating signs and symptoms of dry eye disease. Participants will be randomly assigned to receive either the test solution or placebo.See study design
What are the potential side effects?
Potential side effects may include temporary discomfort in the eyes, redness, blurred vision after application, possible allergic reactions to ingredients in BRM421 Ophthalmic Solution. Specific side effect profiles will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score
Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BRM421 Ophthalmic SolutionActive Control1 Intervention
Group II: VehiclePlacebo Group1 Intervention

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Who is running the clinical trial?

BRIM Biotechnology Inc.Lead Sponsor
3 Previous Clinical Trials
425 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this clinical trial?

"As per clinicaltrials.gov, the medical trial is actively looking for participants - it was originally posted on February 27th 2023 and last updated on September 15th 2023."

Answered by AI

What potential risks are associated with utilizing BRM421 Ophthalmic Solution?

"We rate BRM421 Ophthalmic Solution as a 3, indicating that there is evidence to suggest its efficacy and multiple rounds of research have proven it safe."

Answered by AI

What is the current size of the patient population taking part in this research?

"Affirmative. The clinicaltrials.gov records indicate that, since first being posted on February 27th 2023, this medical trial is actively seeking participants to join their research team. Presently they are recruiting 732 patients from one site specifically."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Andover Eye Associates

Why did patients apply to this trial?

Always looking for the right treatment for my dry eyes.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.
2023. "Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05695781.
All > Dry Eye
~338 spots leftby Apr 2025
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