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

March 4, 2026 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06800
        • Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment of Blepharitis by Demodex Folliculorum Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 8 weeks
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.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-2024/06/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

June 2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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