Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.
Mexico City, 06800, Mexico
NCT Number: NCT07451678
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Mexico City, 06800, Mexico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Instituto de Oftalmología Fundación Conde de Valenciana
Other
Acronym: TBIDFTECWCTC
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.
Published trials that share one or more normalized conditions with this study.
NCT05454956
Blepharitis, Demodex Infestation
Northridge, California, United States
View Trial DetailsNCT06795165
Blepharitis, Eye Diseases
Newport Beach, California, United States
View Trial DetailsNCT06520007
Blepharitis, Doxycycline Adverse Reaction
Milan, MI, Italy
View Trial DetailsNCT05629390
Blepharitis, Eye Diseases
Beijing, Beijing Municipality, China
View Trial Details