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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)

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ClinicalTrials.gov Identifier: NCT02229955
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 29, 2014
First Posted Date  ICMJE September 3, 2014
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE December 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
Corneal staining test [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
  • Corneal staining test [ Time Frame: 4, 8 weeks ]
  • Ocular surface disease index (OSDI) [ Time Frame: 4, 8, 12 weeks ]
  • Tear break up time (TBUT) [ Time Frame: 4, 8, 12 weeks ]
  • Non-anesthetic Schirmer test [ Time Frame: 4, 8, 12 weeks ]
  • Conjunctival staining [ Time Frame: 4, 8, 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE Drug: Cyclosporine ophthalmic solution
1 drop twice/day for 12 weeks to both eyes
Other Names:
  • Restasis Eye Drops
  • Tisporin Eye Drops
Study Arms  ICMJE
  • Experimental: T-sporin eye drop
    Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
    Intervention: Drug: Cyclosporine ophthalmic solution
  • Active Comparator: Restasis eye drop
    Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
    Intervention: Drug: Cyclosporine ophthalmic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2014)
86
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229955
Other Study ID Numbers  ICMJE HL_TSPR_302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hanlim Pharm. Co., Ltd.
Study Sponsor  ICMJE Hanlim Pharm. Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hanlim Pharm. Co., Ltd.
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP