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

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.

Official Title
-----------------
Multicenter, Randomized, Double-blind phⅢ 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.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
* Drug: Restasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 20 or over Patients with moderate to severe dry eye Screening both eyes, the corrected visual acuity is 0.2 or more Exclusion Criteria: Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions. Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) Intraocular pressure(IOP)> 25 mmHg Patient using or to use punctual plug within 1 months. Patients with contact lens.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)<br>CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes | Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)<br>* 1 drop twice/day for 12 weeks to both eyes.<br>* Other names: Cyclosporine Eye Drops(CYPORIN N);|
| Active Comparator: Restasis eye drop<br>Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes | Drug: Restasis<br>* 1 drop twice/day for 12 weeks to both eyes. Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using.<br>* Other names: Cyclosporine Eye Drops (Restasis);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining test |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining test |  | 4, 8 weeks | 
| Conjunctival staining |  | 4, 8, 12 weeks | 
| Corneal and Conjunctival staining sum Score |  | 4, 8, 12 weeks | 
| Ocular surface disease index (OSDI) |  | 4, 8, 12 weeks | 
| Tear break up time (TBUT) |  | 4, 8, 12 weeks | 
| Non-anesthetic Schirmer test |  | 4, 8, 12 weeks | 
| Frequency of concurrent drug use |  | 4, 8, 12 weeks |