Blepharitis
Conditions
Keywords
Demodex, Blepharitis Drug Therapy, Anti-Infective Agents
Brief 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.
Interventions
DRUGEyelid 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.
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Demodex folliculorum count per eyelash | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in eyelash collarette grade | 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. |
| Proportion of participants by Ocular Surface Disease Index (OSDI) severity category | 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. |
Countries
Mexico
Outcome results
None listed