Recruitment

Recruitment Status
Terminated
Estimated Enrollment
20

Summary

Conditions
Anterior Blepharitis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A prospective, randomized, paired-eye trial.Masking: Double (Investigator, Outcomes Assessor)Masking Description: The investigators who assess outcomes of anterior blepharitis will not know the arms that patients are inPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 inc...

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.

Tracking Information

NCT #
NCT04290455
Collaborators
Not Provided
Investigators
Not Provided