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

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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.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop) Drug: Restasis Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
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
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)

Active Comparator: Restasis eye drop
Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes
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)




Primary Outcome Measures :
  1. Corneal staining test [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Corneal staining test [ Time Frame: 4, 8 weeks ]
  2. Conjunctival staining [ Time Frame: 4, 8, 12 weeks ]
  3. Corneal and Conjunctival staining sum Score [ Time Frame: 4, 8, 12 weeks ]
  4. Ocular surface disease index (OSDI) [ Time Frame: 4, 8, 12 weeks ]
  5. Tear break up time (TBUT) [ Time Frame: 4, 8, 12 weeks ]
  6. Non-anesthetic Schirmer test [ Time Frame: 4, 8, 12 weeks ]
  7. Frequency of concurrent drug use [ Time Frame: 4, 8, 12 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461719


Locations
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Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Taejoon Pharmaceutical Co., Ltd.

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Responsible Party: Taejoon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02461719     History of Changes
Other Study ID Numbers: TJCS_P3
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Ophthalmic Solutions
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Pharmaceutical Solutions