Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD
Completed · Phase 2
Conditions studied: Meibomian Gland Dysfunction, Blepharitis, Demodex Infestation
In brief
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, BID vs TID dosing regimens for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation.
Key facts
- Study ID
- NCT05454956
- Run by
- Tarsus Pharmaceuticals, Inc.
- People needed
- 39
- Starts
- 2022-08-03
- Expected to finish
- 2023-05-18
- Last updated by the study team
- 2025-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mitchell C. Shultz, MD — Northridge, California, United States
- Silverstein Eye Center — Kansas City, Missouri, United States
- Oculus Research — Cary, North Carolina, United States
- CORE Inc. — Shelby, North Carolina, United States
- Medical Optometry America — New Freedom, Pennsylvania, United States
Full record on ClinicalTrials.gov
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