NCT02461719

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Taejoon Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndromes

Interventions

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

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2015-06-03
• Last updated: 2015-06-03

Locations

1 site across 1 country: South Korea