A Phase 4 interventional study of Eyelid Cleansing with Wipes Containing Topical Chlorhexidine in Blepharitis, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Phase 4, Interventional, and Treatment
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 39 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Reduction in Demodex folliculorum count per eyelash
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.
Time frame: Baseline and 8 weeks
Change in eyelash collarette grade
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.
Time frame: Baseline and 8 weeks
Proportion of participants by Ocular Surface Disease Index (OSDI) severity category
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.
Time frame: Baseline and 8 weeks
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: June 2026
Ran from Jul 2024 to primary completion in Aug 2024, 1 month.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Instituto de Oftalmología Fundación Conde de Valenciana