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TerminatedNCT04290455Updated Feb 1, 2021

Treatment of Anterior Blepharitis With Microblepharoexfoliation Procedure

An interventional study of Microblepharoexfoliative procedure with BlephEx™ and Eyelid cleansing with eyelid wipes (Optase) in Anterior Blepharitis, sponsored by University of California, Los Angeles. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of recruitment during COVID
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

This study will be prospective, randomized, paired eye trial. Twenty patients with symptomatic 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 will be included in the study. The criteria for grading of lashes contamination is defined as: 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%). Patients will be recruited from the Dry Eye Clinic, Jules Stein Eye Institute, UCLA. The informed consent will be obtained from each patient. 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. Previous topical medications before patients enter the study such as anti-glaucoma medications and artificial tears will be continued.

One of the patients' eyes will be simply randomized into the interventional group in which the BlephExTM device(1) will be used to perform eyelid margin and lash cleansing. The other eye will be entered into the control group in which eyelid cleansing in a conventional way will be done using Optase wipes. In the screening visit, the Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire score and eyelid contamination will be assessed to recruit eligible patients. Before eyelid cleansing, images of the eyelid margin will be obtained by Oculus Keratograph 5M, Wetzlar, Germany and will be used to grade lashes contamination and lid margin redness by two independent observers. Parameters of interest of each eye will be evaluated separately. The primary outcomes are symptoms which will be scored using the Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED)(2) and lashes contamination which will be graded as described above. Other outcomes of interest are lid margin redness, and the number of preservative free artificial tears used per day. The lid margin redness is graded as 0=Clear/white 1=Slight redness 2=Mild redness 3=Moderate redness 4=Severe redness. Patients will also be evaluated for concurrent meibomian gland dysfunction by evaluating meibum quality and expressibility of meibomian glands according to the International Workshop on Meibomian Gland dysfunction 2011(3). Meibum quality is assessed in each of eight glands of the central third of the lower lid on a scale of 0 to 3 for each gland: 0, clear; 1, cloudy; 2, cloudy with debris (granular); and 3, thick, like toothpaste (total score range, 0-24). Expressibility is assessed on a scale of 0 to 3 in five glands in the lower or upper lid, according to the number of glands expressible: 0, all glands; 1, three to four glands; 2, one to two glands; and 3, no glands. Patients who have minimally altered secretion grade ≥ 2-4 and expressibility ≥ 1 will be diagnosed with MGD. The images of eyelids will be taken again immediately after eyelid cleansing and eyelid contamination scores will be evaluated. The patient will then be instructed to perform lid cleansing at home once a day with eyelid cleansing wipes (Optase) for 21 days. The technique will be demonstrated to the patient in clinic. The follow-up visits will be at 21 days. At the follow-up visit, all of the data obtained in the screening visit will be repeated.

02

Conditions studied

  • Anterior Blepharitis

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03

In context

Blepharitis

73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 65 interventional studies indexed under Blepharitis.

Browse Blepharitis studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients who have been given a topical 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.
Terms in these criteria, in plain language(1)

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    treatment arm

    using the microblepharoexfoliative procedure

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

  • Active comparator
    control arm

    using eyelid wipe (Optase)

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

Interventions

  • DeviceMicroblepharoexfoliative procedure with BlephEx™

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

  • ProcedureEyelid cleansing with eyelid wipes (Optase)

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

  • ProcedureDaily 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

06

What researchers measure

Primary outcomes

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

    Time frame: Day 21 after treatment

  2. 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%).

    Time frame: Day 21 after treatment

Secondary outcomes

  1. Lid margin redness

    The lid margin redness is graded as 0=Clear/white 1=Slight redness 2=Mild redness 3=Moderate redness 4=Severe redness.

    Time frame: Baseline and Day 21 after treatment

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

    Time frame: Baseline and Day 21 after treatment

  3. Degree of meibomian gland dysfunction

    Assessment of meibum quality and expressibility of meibomian gland according to the International Workshop on Meibomian Gland dysfunction 2011(3). Meibum quality is assessed in each of eight glands of the central third of the lower lid on a scale of 0 to 3 for each gland: 0, clear; 1, cloudy; 2, cloudy with debris (granular); and 3, thick, like toothpaste (total score range, 0-24). Expressibility is assessed on a scale of 0 to 3 in five glands in the lower or upper lid, according to the number of glands expressible: 0, all glands; 1, three to four glands; 2, one to two glands; and 3, no glands. Patients who have minimally altered secretion grade ≥ 2-4 and expressibility ≥ 1 will be diagnosed with MGD.

    Time frame: Baseline and Day 21 after treatment

07

Study locations

1 site
  • Stein Eye Institute, UCLA
    Los Angeles, California 90095, United States
08

References and documents

Publications

  • 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. PubMed 23846405 ↗
  • 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. PubMed 21450913 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04290455
Responsible party
Saba K. Al-Hashimi, MD (Assistant Professor, University of California, Los Angeles) — Principal investigator
First posted
Mar 2, 2020
Start date
Jun 2, 2020
Primary completion
Nov 1, 2020
Completion
Nov 1, 2020
Last update
Feb 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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