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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taejoon Pharm Co., Ltd.; Taejoon Pharmaceutical Co., Ltd.
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions; Tetrahydrozoline

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.