Treatment of Anterior Blepharitis With Microblepharoexfoliation Procedure

NCT04290455 | Terminated

• 1 other identifier: 20-000084
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change from the baseline of the Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire score 21 days after treatment

  Day 21 after treatment

• Change from the baseline grading of lashes contamination 21 days after treatment

  The criteria for grading of lashes contamination is defined as severity of debris on lashes: 0= Clear lashes, 1=Slight contamination (involvement of lashes \>0 but \<25%), 2=Mild (\>=25% but \< 50%), 3=Moderate (\>=50% but \< 75%), and 4=Severe (\>=75%).

  Day 21 after treatment

Secondary Outcomes (3)

• Lid margin redness

  Baseline and Day 21 after treatment

• Frequency of preservative-free artificial tear eye drops used per day

  Baseline and Day 21 after treatment

• Degree of meibomian gland dysfunction

  Baseline and Day 21 after treatment

Study Arms (2)

treatment arm

EXPERIMENTAL

using the microblepharoexfoliative procedure

Device: Microblepharoexfoliative procedure with BlephEx™; Procedure: Daily eyelid cleansing with eyelid wipes (Optase)

control arm

ACTIVE COMPARATOR

using eyelid wipe (Optase)

Procedure: Eyelid cleansing with eyelid wipes (Optase); Procedure: Daily eyelid cleansing with eyelid wipes (Optase)

Interventions

Microblepharoexfoliative procedure with BlephEx™ DEVICE

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

treatment arm

Eyelid cleansing with eyelid wipes (Optase) PROCEDURE

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

control arm

Daily eyelid cleansing with eyelid wipes (Optase) PROCEDURE

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

control arm; treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- anterior blepharitis with or without meibomian gland dysfunction who have a lash contamination score \>1 and the Standard Patient Evaluation of Eye Dryness Questionnaire score (SPEED score) \>= 1

You may not qualify if:

• Patients who have been given a topical corticosteroid within 6 weeks before entering the study or need a topical corticosteroid or topical antibiotics as an adjunct to lid cleansing will be excluded from the study.
• Patients with concurrent conjunctivitis or keratopathy will also be excluded.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Stein Eye Institute, UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea. 2013 Sep;32(9):1204-10. doi: 10.1097/ICO.0b013e318294b0c0.

  PMID: 23846405 BACKGROUND

• Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1922-9. doi: 10.1167/iovs.10-6997a. No abstract available.

  PMID: 21450913 BACKGROUND

MeSH Terms

Interventions

Granulex

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators who assess outcomes of anterior blepharitis will not know the arms that patients are in
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective, randomized, paired-eye trial.

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 2, 2020
• Study Start: June 2, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (1)