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

Phase 3

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop); Drug: Restasis

• Registration Number: NCT02461719
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2015-05
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-02
• Last Update Submitted: 2015-06-02
• Study First Posted: 2015-06-03
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)	CYPORIN N EYE DROPS 0.05%(TJCS eye drop)	CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes
Restasis eye drop	Restasis	Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes

Primary Outcome Measures

Name	Time	Method
Corneal staining test	12 weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of concurrent drug use	4, 8, 12 weeks
Corneal and Conjunctival staining sum Score	4, 8, 12 weeks
Ocular surface disease index (OSDI)	4, 8, 12 weeks
Tear break up time (TBUT)	4, 8, 12 weeks
Non-anesthetic Schirmer test	4, 8, 12 weeks
Corneal staining test	4, 8 weeks
Conjunctival staining	4, 8, 12 weeks

Trial Locations

Locations (1)

The Catholic University of Korea Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of