Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
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ClinicalTrials.gov Identifier: NCT01957670
Recruitment Status :
(Sponsor decision due to change the clinical indication to Chronic Insomnia)
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Ages Eligible for Study:
18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
Male or female, 18 years of age and over at screening
Diagnosis of mild to moderate Dry Eye, as defined by:
Positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the National Eye Institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; AND
Schirmer Test score (with anesthesia, 5 minutes < 5 mm either eye) ; AND
OSDI score of ≥12 and OSDI score of <33
Main Exclusion Criteria:
Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start.
Any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection
Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening
Receipt of any type of topical artificial eye drops within 3 days prior to screening
Receipt of topical cyclosporine eye drops within 3 months prior to screening