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Anterior BlepharitisNCT04290455

Treatment of Anterior Blepharitis With Microblepharoexfoliation Procedure

A study testing Microblepharoexfoliative procedure with BlephEx™, Eyelid cleansing with eyelid wipes (Optase) and Daily eyelid cleansing with eyelid wipes (Optase) in people with Anterior Blepharitis, run by University of California, Los Angeles at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anterior Blepharitis
What is being tested?
Microblepharoexfoliative procedure with BlephEx™, Eyelid cleansing with eyelid wipes (Optase) and Daily eyelid cleansing with eyelid wipes (Optase)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
2 Jun 2020to 1 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stein Eye Institute, UCLA

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: The Efficacy of Microblephararoexfoliation in the Treatment of Anterior Blepharitis

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.

Being tested
Microblepharoexfoliative procedure with BlephEx™, Eyelid cleansing with eyelid wipes (Optase), Daily eyelid cleansing with eyelid wipes (Optase)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microblepharoexfoliative procedure with BlephEx™Device

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

  • Eyelid cleansing with eyelid wipes (Optase)Procedure or surgery

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

  • Daily eyelid cleansing with eyelid wipes (Optase)Procedure or surgery

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

Study groups in NCT04290455
Study groupRoleWhat they receive
treatment armExperimentalusing the microblepharoexfoliative procedure
Receives: Device: Microblepharoexfoliative procedure with BlephEx™; Procedure: Daily eyelid cleansing with eyelid wipes (Optase)
control armActive comparatorusing eyelid wipe (Optase)
Receives: Procedure: Eyelid cleansing with eyelid wipes (Optase); Procedure: Daily eyelid cleansing with eyelid wipes (Optase)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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%).

    Measured: Day 21 after treatment

Secondary outcomes (3)
  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.

    Measured: Baseline and Day 21 after treatment

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

    Measured: 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.

    Measured: Baseline and Day 21 after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start2 Jun 2020
  3. Primary completion1 Nov 2020
  4. Study completion1 Nov 2020

Why it stopped: Lack of recruitment during COVID

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, randomized, paired-eye trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290455
Sponsor's protocol ID
20-000084
Status last verified
Jan 2021
First submitted
21 Feb 2020
Last updated
1 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Microblepharoexfoliative procedure with BlephEx™, Eyelid cleansing with eyelid wipes (Optase) and Daily eyelid cleansing with eyelid wipes (Optase) in people with Anterior Blepharitis, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of recruitment during COVID). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290455, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.

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