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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Cyclosporine ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-sporin eye drop<br>Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes | Drug: Cyclosporine ophthalmic solution<br>* 1 drop twice/day for 12 weeks to both eyes<br>* Other names: Tisporin Eye Drops;|
| Active Comparator: Restasis eye drop<br>Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes | Drug: Cyclosporine ophthalmic solution<br>* 1 drop twice/day for 12 weeks to both eyes<br>* Other names: Tisporin Eye Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining test |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndromes