A Study to Evaluate the Effectiveness of Using the Heated Eye Pad and Scorpion-1 Touch on Meibomian Gland Dysfunction

Overview

About this study

The purpose of this study is to evaluate the effectiveness of using the Heated Eye Pad and Scorpion-1 Touch to Treat Patients with dry eye symptoms.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 36 participants with evidence of Meibomian Gland (MG) obstruction, based on total Meibomian glands of ≤12 in lower eye lids for each eye will be recruited.
  • Assessment of Meibomian gland obstruction will be conducted by a clinician not involved in the treatment or randomization procedure.
  • Participants must have a positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit.
  • Participants must have a tear break up time < 10 seconds.
  • Participants must agree and have the ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (Ocular lubricants are allowed if no changes are made during the study).
  • Participants must be of age 18 years and older.
  • Any gender or race.
  • Willingness and ability to provide written informed consent to participate in the study.
  • Willingness and ability to return for all study visits.

Exclusion Criteria:

  • Participants will be excluded if they are taking systemic medications with tetracyclin derivatives, antihistamines, isotretinoin or nutritional supplements for MGD that started < 3 months before baseline examination.
  • Participants are excluded if they are taking topical cyclosporine-A or steroids that started < 1 month before baseline examination.
  • Any participant with ocular surgery or trauma < 3 months before baseline examination will be excluded.
  • Participants will be excluded based on the following factors: any eyelid abnormalities, systemic diseases resulting in dry eye, individuals that were treated with LipiFlow in either eye in the last 24 months, individuals using another ophthalmic investigation device or agent within 30 days of study participation, individuals who are unable to complete the required patient questionnaires in English.
  • Additionally excluded are patients who, due to other diseases would not be able to fulfill the follow-up appointments or give an informed consent to the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Joanne Shen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20509617

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