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New eye drops aim to soothe dry eye sufferers

NCT ID NCT04343287

Symptom relief Sponsor: BRIM Biotechnology Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether BRM421 eye drops can safely reduce the signs and symptoms of dry eye compared to a placebo. 220 adults with dry eye for at least 6 months received either the active drops or a placebo. The main outcomes were changes in corneal staining (eye surface damage) and patient-reported dryness after 14 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BRM421 ophthalmic solution (eye drops)
What this could lead to
If successful, BRM421 could offer a new treatment option to reduce eye damage and dryness in people with dry eye syndrome.
What could go wrong
This is an early-to-mid stage trial with only 220 participants. The results may not show a meaningful benefit over placebo, and long-term safety is not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

220 people

The number who actually took part.

Started

Jan 2020

Finished

Jun 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be at least 18 years of age; * Provide written informed consent; * Have a reported history of dry eye for at least 6 months prior to enrollment; * Have a history of use of eye drops Exclusion Criteria: * Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; * Have used any eye drops within 2 hours of Visit 1; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; * Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye syndrome

Contacts and locations

Locations

  • Andover Eye Associates

    Andover, Massachusetts, 01810, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • Midwest Cornea Associates, LLC

    Indianapolis, Indiana, 46290, United States

  • Total Eye Care

    Memphis, Tennessee, 38119, United States

More trials for these conditions

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