Comparison of Meiboleyes® and BRUDER Moist Heat Eye Compress for the treatment of Meibomian Gland Dysfunctio

Not Applicable

Recruiting

• Conditions: Dry eye disease; Meibomian Gland Dysfunction; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12624000175572
• Lead Sponsor: nthalmic Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•Be at least 18 years old.
•Willing to comply with the clinical trial as directed by the Investigator.
•Best-corrected visual acuity of 20/40 or better in each eye at the baseline visit
•Evidence of meibomian gland obstruction (based on a meibomian gland secretion score of less than or equal to 12 for 15 glands of the lower lid) in both eyes at the baseline visit.
•Evidence of active MGD associated signs and symptoms at the baseline visit:
oOSDI questionnaire score more than or equal to 13
oFluorescein TBUT < 10 seconds in both eyes

Exclusion Criteria

•Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca associated with MGD) or uncontrolled systemic disease;
•Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity;
•Ocular hypertension or diagnosed glaucoma;
•Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye at any time or anticipate such a procedure during the study;
•LipiFlow® or other professional in-office lid-heating therapy, meibomian gland probing, or therapeutic gland expression in either eye within 6 months prior to baseline;
•MGD treatments including warm compress therapy, eyelid hygiene, eyelid massage, and manual lid expression within 2 weeks prior to baseline;
•Corneal, conjunctival, or eyelid inflammation (including allergic, vernal, or giant papillary conjunctivitis and mucous membrane pemphigoid) that in the judgment of the investigator may interfere with the study results or the ability of subjects to complete the treatment period;
•Contact lens use anticipated during the study;
•Planned anterior segment surgery (e.g., cataract surgery or any surgery involving a limbal or corneal incision) in either eye during the study period;
•Meibography score at the screening visit of 4 (greater than 75% partial glands using the gestalt grading system);
•Known allergy to spandex or silicone;
•Pregnancy (verbal self-report) or breastfeeding;
•Participation in another clinical trial involving a therapeutic drug or device within the past 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified