Clinical Trial

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

Study acronym: TBIDFTECWCTC
Completed Phase 4
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-03-02; most recent amendment 2026-07-06.
Trial Details
NCT Number NCT07451678
Lead Sponsor Instituto de Oftalmología Fundación Conde de Valenciana
Conditions Blepharitis
Enrollment 39 participants
Start Date 2024-07-01
Primary Completion 2024-08-01 (estimated)
Study Completion 2025-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-08