Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes

Multicenter, Randomized, Double-blind phase ? Study of TJCS Eye Drops group and Restasis Eye Drops group for 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in moderate to severe dry eye disease.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001368

Enrollment

158

Registered

2015-01-30

Start date

2014-01-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental Drug: Cyclosporine ophthalmic nano-emulsion 0.05% (1 drop twice/day for 12 weeks to both eyes) Active Comparator: Cyclosporine ophthalmic solution 0.05% (1 drop twice/day for 12 we

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Corneal staining test	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactKYU-Yeon Hwang

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results