Study evaluating a new drug to treat participants with Demodex blepharitis (inflammation of the eyelids)

Phase 2

Completed

• Conditions: Eyelid inflammation due to a parasitic (Demodex) infestation; Eye Diseases; Dermatitis of eyelid due to Demodex species

• Registration Number: ISRCTN12449602
• Lead Sponsor: Roberto Gonzalez Salinas, MD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-19
• Study Start: 2021-03-11
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
2. Participants must meet all of the following criteria in at least one eye:
2.1. More than 10 collarettes present on the upper lid
2.2. Mild to severe lid margin erythema
2.3. Average Demodex density of 1.5 or more mites per lash
3. Aged =18 years

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. Use of lid hygiene products (eyelid scrubs) in the last 14 days or unwilling to forego the use of lid hygiene products during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified