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 (HL_TSPR_302)

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Cyclosporine ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seocho-Ku
    • Seoul, Seocho-Ku, Korea, Republic of, 137-701
      • The Catholic University of Korea Seoul St. Mary'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corneal staining test	12 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: September 2, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Dry Eye Syndromes
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: HL_TSPR_302