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Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02461719
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Taejoon Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 1, 2015
First Posted Date  ICMJE June 3, 2015
Last Update Posted Date June 3, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
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: June 2, 2015)
  • Corneal staining test [ Time Frame: 4, 8 weeks ]
  • Conjunctival staining [ Time Frame: 4, 8, 12 weeks ]
  • Corneal and Conjunctival staining sum Score [ Time Frame: 4, 8, 12 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 ]
  • Frequency of concurrent drug use [ 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 Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes
Official Title  ICMJE Multicenter, Randomized, Double-blind phⅢ Study of TJCS Eye Drops Group and Restasis Eye Drops Group for 12 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease.
Brief Summary The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
    1 drop twice/day for 12 weeks to both eyes.
    Other Name: Cyclosporine Eye Drops(CYPORIN N)
  • Drug: Restasis
    1 drop twice/day for 12 weeks to both eyes. Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using.
    Other Name: Cyclosporine Eye Drops (Restasis)
Study Arms  ICMJE
  • Experimental: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
    CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes
    Intervention: Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
  • Active Comparator: Restasis eye drop
    Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes
    Intervention: Drug: Restasis
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: June 2, 2015)
158
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age 20 or over
  • Patients with moderate to severe dry eye
  • Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria:

  • Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
  • Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
  • Intraocular pressure(IOP)> 25 mmHg
  • Patient using or to use punctual plug within 1 months.
  • Patients with contact lens.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 NCT02461719
Other Study ID Numbers  ICMJE TJCS_P3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taejoon Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Taejoon Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taejoon Pharmaceutical Co., Ltd.
Verification Date May 2015

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