Trial | NCT02461719  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cyclosporine ...

  • Study Participants

    158
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.
Study Started
Jan 31
2014
Primary Completion
Sep 30
2014
Study Completion
Oct 31
2014
Last Update
Jun 03
2015
Estimate

Drug CYPORIN N EYE DROPS 0.05%(TJCS eye drop)

1 drop twice/day for 12 weeks to both eyes.

  • Other names: Cyclosporine Eye Drops(CYPORIN N)

Drug Restasis

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.

  • Other names: Cyclosporine Eye Drops (Restasis)

CYPORIN N EYE DROPS 0.05%(TJCS eye drop) Experimental

CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes

Restasis eye drop Active Comparator

Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes

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.
No Results Posted