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

NCT02229955 | Completed Phase 3

• 1 other identifier: HL_TSPR_302
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndromes

Keywords

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Corneal staining test

  12 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

T-sporin eye drop

EXPERIMENTAL

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

Drug: Cyclosporine ophthalmic solution

Restasis eye drop

ACTIVE COMPARATOR

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

Drug: Cyclosporine ophthalmic solution

Interventions

Cyclosporine ophthalmic solution DRUG

1 drop twice/day for 12 weeks to both eyes

Also known as: Restasis Eye Drops, Tisporin Eye Drops

Restasis eye drop; T-sporin eye drop

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Patients with moderate-to-severe ocular dry eye\]
• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

The catholic university of Korea seoul st. Mary's hospital

Seoul, Seocho-Ku, 137-701, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-08

Locations

KR (1)