Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03953118
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic Meibomian gland disease, defined as patient-reported ocular surface symptoms such as dryness, grittiness, foreign body sensation, or eye fatigue in combination with clinically identifiable Meibomian gland disease with Grade 2 or greater involvement on the Meibomian Gland Grading Scale (Section XV, item 2).
* OSDI Score greater than or equal to 20
* Ability to give informed consent
Exclusion Criteria:
* Age less than 18 years
* Allergy or intolerance to oral azithromycin or topical dexamethasone
* Allergy or intolerance to the preservatives used in topical ophthalmic 0.1% dexamethasone: sodium bisulfite, phenylethyl alcohol, benzalkonium chloride
* History of prolonged QT interval, history of torsades des pointes, congenital long QT syndrome, bradyarrhythmias, heart failure
* Patients currently taking medications that prolong the QT interval (Table 1)
* Aqueous deficiency dry eye defined as Schirmer's strip testing without anesthesia with £ 5mm of tears on two separate tests.
* Ocular surface inflammatory disease, including cicatrizing conjunctivitis, graft versus host disease, Stevens Johnson syndrome
* Atopic disease with ocular involvement
* Limbal stem cell deficiency
* Oral or topical ophthalmic antibiotic use within the last 90 days
* Oral prednisone use \>5mg per day
* Topical ophthalmic steroid use within the past 30 days
* Topical ophthalmic anti-inflammatory (including non-steroidal anti-inflammatory medications, lifitegrast, or cyclosporine) use within the past 30 days
* Patients who are currently pregnant, planning on becoming pregnant during the study period, or currently breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03953118
Study Brief:
Protocol Section:
NCT03953118