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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Restasis
Sponsored by
Taejoon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Catholic University of Korea Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CYPORIN N EYE DROPS 0.05%(TJCS eye drop)

Restasis eye drop

Arm Description

CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes

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

Outcomes

Primary Outcome Measures

Corneal staining test

Secondary Outcome Measures

Corneal staining test
Conjunctival staining
Corneal and Conjunctival staining sum Score
Ocular surface disease index (OSDI)
Tear break up time (TBUT)
Non-anesthetic Schirmer test
Frequency of concurrent drug use

Full Information

First Posted
June 1, 2015
Last Updated
June 2, 2015
Sponsor
Taejoon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02461719
Brief Title
Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taejoon Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Arm Type
Experimental
Arm Description
CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes
Arm Title
Restasis eye drop
Arm Type
Active Comparator
Arm Description
Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes
Intervention Type
Drug
Intervention Name(s)
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Other Intervention Name(s)
Cyclosporine Eye Drops(CYPORIN N)
Intervention Description
1 drop twice/day for 12 weeks to both eyes.
Intervention Type
Drug
Intervention Name(s)
Restasis
Other Intervention Name(s)
Cyclosporine Eye Drops (Restasis)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Corneal staining test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Corneal staining test
Time Frame
4, 8 weeks
Title
Conjunctival staining
Time Frame
4, 8, 12 weeks
Title
Corneal and Conjunctival staining sum Score
Time Frame
4, 8, 12 weeks
Title
Ocular surface disease index (OSDI)
Time Frame
4, 8, 12 weeks
Title
Tear break up time (TBUT)
Time Frame
4, 8, 12 weeks
Title
Non-anesthetic Schirmer test
Time Frame
4, 8, 12 weeks
Title
Frequency of concurrent drug use
Time Frame
4, 8, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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