Study of Tisporin Eye Drops group and Restasis Eye Drops group after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease

A Multicenter, Randomized, Double-blind phase ? Study of Tisporin Eye Drops group and Restasis EyeDrops group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001229

Enrollment

Registered

2014-09-18

Start date

2013-12-13

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Cyclosporin 0.05% eye drops (Control : Lestasis™, Test : T-sporin™) One drop in each eye two times per day, 12 weeks of treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [Patients with moderate-to-severe ocular dry eye] 1) The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading) 2) Non-anesthetic Schirmer test value = 10mm/5min patients at least one eye score (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye, Schirmer test value = 3mm/5min) 3) Tear break-up time is 10 seconds or less 4) Screening both eyes, the corrected visual acuity is 0.2 or more 5) Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)

Exclusion criteria

Exclusion criteria: 1) Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions. 2) The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) a. Abnormal eyelid function : Disoders of the eyelids or eyelashes b. Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.) c. Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation 3) current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status 4) The use in clinical trials of drug hypersensitivity reactions in patients

Design outcomes

Primary

Measure	Time frame
Corneal staining test	—

Secondary

Measure	Time frame
Corneal staining test ;Ocular surface disease index (OSDI) ;Tear break up time (TBUT) ;Non-anesthetic Schirmer test ;Conjunctival staining	—

Countries

Korea, Republic of

Contacts

Public ContactKyu Hwang

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results