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

Dry Eye Syndromes Clinical Trial

— HL_TSPR_302  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229955
• Other study ID #: HL_TSPR_302
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2014
• Last updated: September 2, 2014
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Minisrty of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cyclosporine ophthalmic solution
1 drop twice/day for 12 weeks to both eyes

Locations

Country	Name	City	State
Korea, Republic of	The catholic university of Korea seoul st. Mary's hospital	Seoul	Seocho-Ku

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal staining test		12 weeks	No
Secondary	Corneal staining test		4, 8 weeks	No
Secondary	Ocular surface disease index (OSDI)		4, 8, 12 weeks	No
Secondary	Tear break up time (TBUT)		4, 8, 12 weeks	No
Secondary	Non-anesthetic Schirmer test		4, 8, 12 weeks	No
Secondary	Conjunctival staining		4, 8, 12 weeks	No