New eye drops aim to zap redness fast in kids and adults
NCT ID NCT06538662
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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283 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Apr 2025
- Lead sponsor
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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
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Advancing Vision Research, LLC
Smyrna, Tennessee, 37167, United States
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Alamo Pediatric Eye Center, PLLC
San Antonio, Texas, 78249, United States
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Andover Eye Associates
Andover, Massachusetts, 01810, United States
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Butchertown Clinical Trials
Louisville, Kentucky, 40206, United States
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CORE, Inc.
Shelby, North Carolina, 28150, United States
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Canyon City Eyecare
Azusa, California, 91702, United States
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Eye Research Foundation
Newport Beach, California, 92663, United States
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NC Eye Associates, OD, PLLC
Apex, North Carolina, 27502, United States
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Total Eye Care PA
Memphis, Tennessee, 38119, United States
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Vision Institute
Colorado Springs, Colorado, 80907, United States
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