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Exploratory Vehicle for Meibomian Gland Dysfunction (Rhea Trial)

Phase 2

Waitlist Available

Led By Mitchell C Shultz, MD

Research Sponsored by Tarsus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 85 days

Awards & highlights

Rhea Trial Summary

This trial tests two dosing regimens of a drug to see which is best for treating people with MGD caused by Demodex lid infestation.

Who is the study for?

This trial is for individuals with Demodex eyelid infestation and meibomian gland dysfunction, who have specific symptoms like lashes with collarettes, mites on the lids, lid erythema, short tear breakup time, and at least some functioning meibomian glands. Participants must not use lid hygiene products or contact lenses during the study and should not be pregnant or using systemic antihistamines recently.Check my eligibility

What is being tested?

The study tests an Exploratory Vehicle (EV) of TP-03 medication to see if taking it twice a day (BID) versus three times a day (TID) affects the function of meibomian glands in patients with Demodex eyelid infestation differently.See study design

What are the potential side effects?

While specific side effects are not listed here, potential side effects may include irritation at the application site, allergic reactions to ingredients in EV of TP-03, or exacerbation of eye conditions due to changes in treatment regimen.

Rhea Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 85 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~85 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment Emergent Adverse Events (TEAEs)

Secondary outcome measures

Change from baseline in lid margin erythema.

Change from baseline in lower lid meibomian gland secretion score

Change from baseline in tear breakup time assessed via slit lamp

Rhea Trial Design

3Treatment groups

Experimental Treatment

Group I: Study Cohort 3Experimental Treatment1 Intervention

Participants are randomized to receive TID administration of EV for approximately 85 days

Group II: Study Cohort 2Experimental Treatment1 Intervention

Participants are randomized to receive BID administration of EV for approximately 85 days.

Group III: Study Cohort 1Experimental Treatment1 Intervention

Participants who were previously enrolled, dosed, and completed approximately 43 days of TID EV administration. Participants are crossed over to receive BID administration of EV for approximately 43 additional days.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Tarsus Pharmaceuticals, Inc.Lead Sponsor

9 Previous Clinical Trials

1,239 Total Patients Enrolled

1 Trials studying Meibomian Gland Dysfunction

40 Patients Enrolled for Meibomian Gland Dysfunction

Mitchell C Shultz, MDPrincipal InvestigatorShultz Chang Vision

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cohort 1 of this study received the FDA's stamp of approval?

"Considering this to be a Phase 2 trial with evidence of safety but no proof of efficacy, our team at Power gave Study Cohort 1 a rating of two on the scale."

Answered by AI

Is this research effort currently enrolling new participants?

"Per the clinicaltrials.gov database, this medical trial is actively recruiting patients. It was initially posted on August 1st 2023 and most recently updated September 19th 2023."

Answered by AI

How many participants are involved in this research endeavor?

"Affirmative. Clinicaltrials.gov states that this research endeavour, which was originally posted on August 1st 2023, is actively seeking enrollees at the moment. At two different medical sites, 36 people are needed to participate in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex

2023. "Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054217.

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