New eyedrop shows promise for Mite-Related dry eye
NCT ID NCT05454956
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.
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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
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Silverstein Eye Center
Kansas City, Missouri, 64133, United States
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