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

Last updated: June 2, 2015
Sponsor: Taejoon Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Eyelid Inflammation

Sjogren's Syndrome

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT02461719
TJCS_P3
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Screening visits within 4 weeks who treated with systemic cyclosporine or topicalcyclosporine ophthalmic solutions.

  • Screening visits within 2 months the patients with systemic or ocular disordersaffected 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.

Study Design

Total Participants: 158
Study Start date:
January 01, 2014
Estimated Completion Date:
October 31, 2014

Connect with a study center

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

    Seoul,
    Korea, Republic of

    Site Not Available

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