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

Phase 3

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Cyclosporine ophthalmic solution

• Registration Number: NCT02229955
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-09-02
• Last Update Submitted: 2014-09-02
• Study First Posted: 2014-09-03
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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)

   1. Abnormal eyelid function : Disoders of the eyelids or eyelashes
   2. Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
   3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T-sporin eye drop	Cyclosporine ophthalmic solution	Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
Restasis eye drop	Cyclosporine ophthalmic solution	Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes

Primary Outcome Measures

Name	Time	Method
Corneal staining test	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The catholic university of Korea seoul st. Mary's hospital; 🇰🇷 Seoul, Seocho-Ku, Korea, Republic of