Study evaluating a new drug for the treatment of blepharitis (eyelid inflammation) due to Demodex (mite) infestatio

Phase 2

Completed

• Conditions: Blepharitis due to Demodex infestation; Infections and Infestations

• Registration Number: ISRCTN24398865
• Lead Sponsor: Tarsus Pharmaceuticals, Inc.

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34415795/ (added 23/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-20
• Study Start: 2021-05-17
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Subjects greater or equal to 18 years of age with blepharitis due to Demodex infestation
2. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
3. Participants must meet the following criteria in at least one eye: Have more than 10 collarettes present on the upper lid or an average Demodex density, upper and lower eyelids combined, of at least 1.5 mites per lash

Exclusion Criteria

1. Systemic or topical antibacterial, antiparasitic or anti-inflammatory steroid treatment within the last 14 days
2. Topical tea tree oil or hypochlorous acid treatment of the ophthalmic area within the last 14 days
3. The use of lid hygiene products (lid scrubs) within the last 14 days or unwilling to forego the use of lid hygiene products during the study treatment phase
4. Contact lens wear within the last 7 days or unwilling to forego contact lens wear during the study treatment phase

Study & Design

• Study Type: Interventional
• Study Design: Not specified