NCT07451678

Treatment of Blepharitis Induced by Demodex Folliculorum Through Eyelid Cleansing With Wipes Containing Topical Chlorhexidine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study employed an experimental, prospective, longitudinal, before-and-after design to evaluate the efficacy of topical chlorhexidine wipes in treating blepharitis. The investigation focused on assessing signs and symptoms associated with Demodex Folliculorum blepharitis, including telangiectasia, ocular irritation, collarettes, foreign body sensation, tearing, eyelid erythema, and dry eye. Each subject underwent an assessment of the Demodex Folliculorum infection index through the epilation of four eyelashes, followed by direct visualization using optical microscopy. Additionally, the number of eyelashes with collarettes was categorized and graded as follows: Grade 0: 0-2 eyelashes per eyelid with collarettes; Grade 1: 3-10 eyelashes per eyelid with collarettes; Grade 2: ≥10 to ≤1/3; Grade 3: ≥1/3 - ≤2/3; Grade 4: ≥2/3 of eyelashes per eyelid with collarettes. Participants applied topical chlorhexidine wipes twice daily, in the morning and evening, to cleanse the eyelash area of both eyelids over a period of four weeks. A follow-up assessment was conducted at four weeks, during which another Demodex test was performed to ascertain the presence of the microorganism. At week ten, the same signs and symptoms evaluated in the initial assessment were re-evaluated for follow-up.

Conditions

• Blepharitis

Interventions

Type	Name	Description
DRUG	Eyelid Cleansing with Wipes Containing Topical Chlorhexidine	Participants applied topical chlorhexidine wipes twice daily, in the morning and evening, to cleanse the eyelash area of both eyelids over a period of four weeks. A follow-up assessment was conducted at four weeks, during which another Demodex test was performed to ascertain the presence of the microorganism. At week ten, the same signs and symptoms evaluated in the initial assessment were re-evaluated for follow-up.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-08-01
• Completion: 2025-01-31
• First posted: 2026-03-05
• Last updated: 2026-03-06

Locations

1 site across 1 country: Mexico