None listed
Conditions
Brief summary
The purpose of this trial is to assess the feasibility of a novel eye heating device for the treatment of meibomian gland dysfunction in adults with the condition compared to a commercially available heating eye mask. Various ocular observations and questionnaires will be used to assess the feasilbility.
Interventions
This will be a prospective, bilateral, randomised, parallel clinical trial. Participants will be assigned to use either the test device (Meiboleyes) or the control device (BRUDER).
Each participant will attend 3 visits of approximately 60min duration each, comprising of visit 1 (baseline/screening), visit 2 (2 weeks from baseline) and visit 3 (6 weeks from baseline). Their allocated study product will be dispensed at visit 1 and used for the duration of the study.
All visits are carried out by
This will be a prospective, bilateral, randomised, parallel clinical trial. Participants will be assigned to use either the test device (Meiboleyes) or the control device (BRUDER). Each participant will attend 3 visits of approximately 60min duration each, comprising of visit 1 (baseline/screening), visit 2 (2 weeks from baseline) and visit 3 (6 weeks from baseline). Their allocated study product will be dispensed at visit 1 and used for the duration of the study. All visits are carried out by an optometrist and will comprise standard optometric assessments including visual acuity, subjective refraction (visit 1 only), slit lamp biomicroscopy for general ocular assessment as well as assessment of the meibomian glands and tear film. Questionnaires will also be administered. Participants will be instructed to use their allocated study product twice per day, for 10-15 minutes each time. Both study products are heated then worn over the closed eyes, with the products fastened around the head with an elasticised strap. Meiboleyes is battery charged and heated through the press of a button and BRUDER is heated in the microwave. A diary will be deployed to collect product usage and assess compliance with the wear regime.
Sponsors
nthalmic Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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: o OSDI questionnaire score more than or equal to 13 o Fluorescein 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.
Outcome results
None listed