HL_TSPR_302: 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

Sponsor

Hanlim Pharm. Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02229955

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Cyclosporine ophthalmic solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T-sporin eye drop Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes	Drug: Cyclosporine ophthalmic solution 1 drop twice/day for 12 weeks to both eyes Other Names: Restasis Eye Drops Tisporin Eye Drops
Active Comparator: Restasis eye drop Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes	Drug: Cyclosporine ophthalmic solution 1 drop twice/day for 12 weeks to both eyes Other Names: Restasis Eye Drops Tisporin Eye Drops

Arm

Intervention/Treatment

Experimental: T-sporin eye drop

Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes

Drug: Cyclosporine ophthalmic solution

1 drop twice/day for 12 weeks to both eyes

Other Names:

Restasis Eye Drops

Tisporin Eye Drops

Active Comparator: Restasis eye drop

Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes

Drug: Cyclosporine ophthalmic solution

1 drop twice/day for 12 weeks to both eyes

Other Names:

Restasis Eye Drops

Tisporin Eye Drops

Outcome Measures

Primary Outcome Measures

Corneal staining test [12 weeks]

Secondary Outcome Measures

Corneal staining test [4, 8 weeks]
Ocular surface disease index (OSDI) [4, 8, 12 weeks]
Tear break up time (TBUT) [4, 8, 12 weeks]
Non-anesthetic Schirmer test [4, 8, 12 weeks]
Conjunctival staining [4, 8, 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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