Phase
Condition
Sjogren's Syndrome
Dry Eyes
Dry Eye Disease
Treatment
N/AClinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
[Patients with moderate-to-severe ocular dry eye]
The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
Non-anesthetic Schirmer test value ≤ 10mm/5min patients at least one eye score (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye,Schirmer test value ≥ 3mm/5min)
Tear break-up time is 10 seconds or less
Screening both eyes, the corrected visual acuity is 0.2 or more
Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eyedrops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant,etc.)
Exclusion
Exclusion Criteria:
Screening visits in the previous 3 months (12 weeks) who participated in the clinicaltrials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
The patients with systemic or ocular disorders affected the test results (ocularsurgery, trauma, or disease)
Abnormal eyelid function : Disoders of the eyelids or eyelashes
Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctivalscarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid),pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis,keratoconus, corneal transplantation
current or recent patients used dry eye syndrome medications (topical or systemic)that may affect the status
The use in clinical trials of drug hypersensitivity reactions in patients
Study Design
Connect with a study center
The catholic university of Korea seoul st. Mary's hospital
Seoul, Seocho-Ku 137-701
Korea, Republic ofSite Not Available
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