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Treatment of Anterior Blepharitis With Microblepharoexfoliation Procedure

NCT04290455 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-02-01

No results posted yet for this study

Summary

Objective: To investigate the efficacy of microblepharoexfoliation by BlephEx™ as an adjunct to eyelid cleansing in the treatment of anterior blepharitis and to validate the grading score of lid contamination to describe the severity of anterior blepharitis. Design: A prospective, randomized, paired-eye trial. Methods: One of patients' eyes will be randomized into the microblepharoexfoliation group which will use the BlephExTM device during the in-house lid cleansing procedure. The other eye will be in the control group which will receive conventional lid cleansing. The parameters indicating the efficacy of the microblepharoexfoliation procedure including the symptom scoring system; the Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED), lashes contamination, lid margin redness, number of preservative free artificial tears used per day, meibomian gland quality and expressibility will be recorded at the screening visit and 3-week follow-up visit. The patient will be instructed to do warm compression and lid cleansing at home once a day with Optase eyelid scrubs for 3 weeks on both eyes before follow-up.

Conditions

  • Anterior Blepharitis

Interventions

DEVICE

Microblepharoexfoliative procedure with BlephEx™

The device will be used to clean both upper and lower eyelid in the office visit.

PROCEDURE

Eyelid cleansing with eyelid wipes (Optase)

Eyelid cleansing will be done with eyelid wipes (Optase) by one clinician

PROCEDURE

Daily eyelid cleansing with eyelid wipes (Optase)

Patients in both arms will be instructed to do self-eyelid cleansing with eyelid wipes (Optase) daily at home for 21 days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2020-11-01
Completion
2020-11-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290455 on ClinicalTrials.gov