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Completed

NCT Number: NCT07451678

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

Mexico City, 06800, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Clinical diagnosis of Demodex folliculorum blepharitis
  • Presence of eyelash collarettes on slit-lamp examination
  • Positive identification of Demodex folliculorum by epilation of 4 upper and 4 lower eyelashes per eyelid and visualization under light microscopy
  • Willingness to use chlorhexidine eyelid wipes as instructed for 8 weeks

Exclusion criteria

  • Use of topical or systemic antiparasitic treatment within the past 6 weeks
  • Use of topical ophthalmic antibiotics or anti-inflammatory medication within the past 6 weeks
  • Known allergy or hypersensitivity to chlorhexidine
  • Pregnancy or breastfeeding

Treatment and study plan

Eyelid Cleansing with Wipes Containing Topical Chlorhexidine

Drug

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.

Primary outcomes

  1. Reduction in Demodex folliculorum count per eyelash

    Time frame: Baseline and 8 weeks

    Mean number of Demodex folliculorum mites per eyelash (mites/lash) assessed by epilation of 4 eyelashes from the upper eyelid and 4 eyelashes from the lower eyelid and examination under light microscopy at 40× magnification. The outcome will be reported as the change in mean mites/lash from baseline to 8 weeks after treatment with chlorhexidine eyelid wipes.

Secondary outcomes

  1. Change in eyelash collarette grade

    Time frame: Baseline and 8 weeks

    Proportion of eyelashes with collarettes per eyelid assessed by slit-lamp examination and graded using a standardized 0-4 scale:

    Grade 0: 0-2 lashes; Grade 1: 3-10 lashes; Grade 2: >10 lashes to ≤1/3 of lashes; Grade 3: >1/3 to ≤2/3 of lashes; Grade 4: >2/3 of lashes per eyelid. The outcome will be reported as change in grade from baseline to 8 weeks.

  2. Proportion of participants by Ocular Surface Disease Index (OSDI) severity category

    Time frame: Baseline and 8 weeks

    Proportion of participants classified according to Ocular Surface Disease Index (OSDI) severity category based on the validated 12-item OSDI questionnaire (0-100 scale). Severity categories will be defined as:

    Normal (0-12), Mild (13-22), Moderate (23-32), and Severe (33-100). The outcome will be expressed as the percentage of participants in each severity category at baseline and at 8 weeks after treatment with chlorhexidine eyelid wipes.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Acronym: TBIDFTECWCTC

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 5, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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