Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Silk Technologies, Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have DED in both eyes, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.
Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.
Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.
Anesthetized Schirmer's test tear volume ≥ 3 mm and \<10 mm in both eyes (only at Visit 1).
Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.
You may not be if
Ocular surface corneal disease other than DED.
Diagnosis of Sjögren's disease.
Lid margin disorder other than meibomian gland dysfunction (MGD)
Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.
Any previous reconstructive or cosmetic eyelid surgery
Any previous invasive glaucoma and/or corneal surgery
Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
Cataract extraction within 90 days prior to Visit 1/Screening.
Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study.
Contact lens wear.
Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening
Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments
