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

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.

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.

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.