Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD
- Conditions
- BlepharitisDemodex InfestationMeibomian Gland Dysfunction
- Interventions
- Drug: TP-03 Vehicle
- Registration Number
- NCT05454956
- Lead Sponsor
- Tarsus Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
This Phase 2a study is a randomized, two-arm, double-masked, multicenter, parallel pilot study to compare the safety and efficacy of two dosing regimens of TP-03, BID vs TID, for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation. The primary objective of the study is to assess the safety and efficacy of two dosing regimens of TP-03, 0.25% from Day 1 to Day 85 in adult participants with meibomian gland dysfunction in the presence of Demodex infestation. Efficacy will be determined by assessing lower lid meibomian gland secretion, lid margin erythema, bulbar redness, tear breakup time, ocular surface staining, and dry eye symptoms. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity and slit lamp biomicroscopy from baseline.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BID Dosing TP-03 TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days BID Dosing TP-03 Vehicle TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days TID Dosing TP-03 TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Events (TEAEs) 85 days TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Medical Optometry America
🇺🇸New Freedom, Pennsylvania, United States
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