Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0001368
- Lead Sponsor
- Taejoon Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 158
1)Male or female, age 20 or over
2)Patients with moderate to severe dry eye
(1)The score of study eye corneal fluorescein staining score of 2 or higher(Oxford grade)
(2)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)
3)Screening both eyes, the corrected visual acuity is 0.2 or more
4)Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)
5)Negative urine pregnancy test at the screening when women of childbearing age
6)Medically reliable method of contraception in the case of all women of childbearing age or menopause
7)Written consent voluntarily to participate in this clinical trial
1)Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
2)Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
3)Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
4)Intraocular pressure(IOP)> 25 mmHg
5)Hypersensitivity to the investigational products or be suspicious to them
6)Patients with contact lens.
7)If you use or plan to use punctual plug within 1 months.
8)Lacrimal punctual occlusion surgery patients
9)Screening visit within 3 months the patients with Ocular surgery
10)Pregnancy or breastfeeding
11)Patients who have been diagnosed be the end of the lacrimal gland disease on the past history.
12)History of malignancy
13)If you are receiving systemic steroids or immunosuppressive treatment
14)In patients with severe renal failure (serum creatinine more than 2.0 times the upper limit of normal)
15)In patients with severe liver dysfunction (ALT or AST of more than 2.0 times the upper limit of normal)
16)Alcohol or drug abuse
17)Participating in a Clinical Trial patients who have participated in other clinical trials within two months
18)Patients whom the investigator considers inappropriate to participate in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Corneal staining test
- Secondary Outcome Measures
Name Time Method Corneal staining test ;Conjunctival staining ;Corneal and Conjunctival staining sum Score ;Ocular surface disease index (OSDI) ;Tear break up time (TBUT) ;Non-anesthetic Schirmer test ;Frequency of concurrent drug use