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

Dry Eye Syndromes Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461719
• Other study ID #: TJCS_P3
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2015
• Last updated: June 2, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Taejoon Pharm Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taejoon Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal staining test		12 weeks
Secondary	Corneal staining test		4, 8 weeks
Secondary	Conjunctival staining		4, 8, 12 weeks
Secondary	Corneal and Conjunctival staining sum Score		4, 8, 12 weeks
Secondary	Ocular surface disease index (OSDI)		4, 8, 12 weeks
Secondary	Tear break up time (TBUT)		4, 8, 12 weeks
Secondary	Non-anesthetic Schirmer test		4, 8, 12 weeks
Secondary	Frequency of concurrent drug use		4, 8, 12 weeks