Phase
Condition
Dry Eye Disease
Sjogren's Syndrome
Dry Eyes
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 sum of corneal fluorescein staining score of 5 or higher (NEI Scale)
Non-anesthetic Schirmer test value ≤ 5mm/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)
Screening both eyes, the corrected visual acuity is 0.2 or more
Despite conventional treatment, the symptoms of dry eye signs (Artificial teareye drops, sympathetic nervous system stimulant agent, parasympathetic nervestimulant, etc.)
Negative urine pregnancy test at the screening when women of childbearing age
Medically reliable method of contraception in the case of all women ofchildbearing age or menopause (1 year after the last menstrual period women)Sterilization (eg, bilateral oophorectomy, hysterectomy) women of childbearingage have not been effective contraception only if you participate in a clinicaltrial may have been determined to be pregnant by examining whether the voice,maintained during the entire clinical trial period shall that.
Written consent voluntarily to participate in this clinical trial
Exclusion
Exclusion Criteria:
- Screening visits in the previous 3 months (12 weeks) who participated in theclinical trials of cyclosporine eye drops, or if you used a cyclosporine ophthalmicsolutions.
- 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 3) current or recent patients used dry eyesyndrome medications (topical or systemic) that may affect the status 4) The usein clinical trials of drug hypersensitivity reactions in patients 5) patientswith contact lens 6) If you use or plan to use punctual plug within 4 weeks 7)Lacrimal punctual occlusion surgery patients 8) Ocular surgery within 3 months (12 weeks) 9) Pregnant women, lactating, or planning to become pregnant 10) Theend of the lacrimal gland disease (Nasal stimulation Schirmer test value <3mm/5min) 11) History of malignancy 12) If you are receiving systemic steroidsor immunosuppressive treatment 15) In patients with severe renal failure (serumcreatinine more than 2.0 times the upper limit of normal) 16) In patients withsevere liver dysfunction (ALT or AST of more than 2.0 times the upper limit ofnormal) 17) Alcohol or drug abuse 18) Pregnant women, lactating women 19)Participating in a Clinical Trial patients who have participated in otherclinical trials within three months 20) Patients judged coexisting disease thatcould interfere with the completion of the treatment or safety of this clinicaltrial. Patients that other researchers are determined inadequately
Study Design
Study Description
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
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.