A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease

Hanlim Pharm. Co., Ltd.1 site in 1 country86 target enrollmentDecember 2013

ConditionsDry Eye Syndromes

InterventionsCyclosporine ophthalmic solution

DrugsCyclosporine ophthalmic solution

Overview

Phase: Phase 3
Intervention: Cyclosporine ophthalmic solution
Conditions: Dry Eye Syndromes
Sponsor: Hanlim Pharm. Co., Ltd.
Enrollment: 86
Locations: 1
Primary Endpoint: Corneal staining test
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) 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.

Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanlim Pharm. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\[Patients with moderate-to-severe ocular dry eye\]
•The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
•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)
•Tear break-up time is 10 seconds or less
•Screening both eyes, the corrected visual acuity is 0.2 or more
•Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)

Exclusion Criteria

•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.
•The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
•Abnormal eyelid function : Disoders of the eyelids or eyelashes
•Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
•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
•current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
•The use in clinical trials of drug hypersensitivity reactions in patients