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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02461719

Enrollment

158

Registered

2015-06-03

Start date

2014-01-31

Completion date

2014-10-31

Last updated

2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

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.

Interventions

DRUGCYPORIN N EYE DROPS 0.05%(TJCS eye drop)

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

DRUGRestasis

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Corneal staining test	12 weeks

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026