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New eyedrop shows promise for Mite-Related dry eye

NCT ID NCT05454956

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an eyedrop called TP-03 in 39 people with meibomian gland dysfunction (a common cause of dry eye) linked to Demodex mites. The goal was to compare two dosing schedules (twice vs. three times daily) for safety and effectiveness. The results could lead to a new treatment for this uncomfortable condition.

What this could mean

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

Active substance
TP-03 (lotilaner ophthalmic solution 0.25%)
What this could lead to
If successful, this could lead to a new eyedrop treatment for dry eye and eyelid inflammation caused by Demodex mites.
What could go wrong
This is a small, early Phase 2 pilot study with only 39 participants. The results may not apply to everyone, and the treatment may not prove effective or safe in larger trials.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Aug 2022

Finished

May 2023

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 willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites in the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid Exclusion Criteria: * Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the use of lid hygiene products during the study * Have used systemic antihistamines within 30 days of Day 1 * Have used artificial eyelashes, eyelash extensions or had other cosmetic eyelash or eyelid procedures within 7 days of Day 1 or be unwilling to forego their use during the study * Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the duration of the study * Be pregnant or lactating at Day 1

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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

  • CORE Inc.

    Shelby, North Carolina, 28150, United States

  • Medical Optometry America

    New Freedom, Pennsylvania, 17349, United States

  • Mitchell C. Shultz, MD

    Northridge, California, 91325, United States

  • Oculus Research

    Cary, North Carolina, 27513, United States

  • Silverstein Eye Center

    Kansas City, Missouri, 64133, United States

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