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

Taejoon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: Restasis; Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02461719

TJCS_P3

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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158 participants in 2 patient groups

CYPORIN N EYE DROPS 0.05%(TJCS eye drop)

Experimental group

Description:

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

Treatment:

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

Restasis eye drop

Active Comparator group

Description:

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

Treatment:

Drug: Restasis