New eye drops aim to zap redness fast in kids and adults

NCT ID NCT06538662

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 ยท Last updated Jun 27, 2026

Summary

This completed Phase 3 trial tested whether FID 123320 eye drops can safely reduce eye redness caused by minor irritations. The study involved 283 children and adults who used either the active drops or a placebo. Researchers measured redness at several time points, from 1 minute to 10 hours after use.

What this could mean

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

Active substance
FID 123320 ophthalmic solution
What this could lead to
If successful, this could provide a new over-the-counter option for quickly and safely reducing eye redness from minor irritations.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The effect may be modest or similar to existing redness relief drops, and long-term safety data are limited.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

283 people

The number who actually took part.

Started

Oct 2024

Finished

Apr 2025

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

5 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.

Key Inclusion Criteria - Adult Cohort: * Capable of giving signed informed consent; * Willing and able to follow all instructions and attend all study visits; * Able to self-administer eye drops in the opinion of the investigator; * Have a history of vasoconstrictor (redness relief drop) use within the last 6 months, have an interest in using over-the-counter (OTC) vasoconstrictor eye drops for redness relief, or would benefit from the use of redness relief drops in the opinion of the investigator; * Ocular health within normal limits, including distance best corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart; * Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study; * Other protocol-defined inclusion criteria may apply. Key Inclusion Criteria - Pediatric Cohort: * All pediatric subjects: Parent or legal guardian signs informed consent; * Pediatric subject ages 7-17: Sign an assent form; * Subject and parent/legal guardian/care giver: Willing and able to follow all instructions and attend all study visits; * Able to self-administer eye drops satisfactorily or have a subject's care provider or parent/legal guardian at home routinely available for this purpose; * Ocular health within normal limits; best-corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart; * Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study; * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria - Pediatric and Adult Cohorts * Known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol; * Ocular surgical intervention within 6 months prior to Visit 1 (Day -7 to Day -1) or during the study; * History of lid surgery; * Ocular condition that, in the opinion of the investigator, could affect the subject's safety or study parameters; * Other protocol-specified exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Advancing Vision Research, LLC

    Smyrna, Tennessee, 37167, United States

  • Alamo Pediatric Eye Center, PLLC

    San Antonio, Texas, 78249, United States

  • Andover Eye Associates

    Andover, Massachusetts, 01810, United States

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206, United States

  • CORE, Inc.

    Shelby, North Carolina, 28150, United States

  • Canyon City Eyecare

    Azusa, California, 91702, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • NC Eye Associates, OD, PLLC

    Apex, North Carolina, 27502, United States

  • Total Eye Care PA

    Memphis, Tennessee, 38119, United States

  • Vision Institute

    Colorado Springs, Colorado, 80907, United States

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