Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes
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.
1 other identifier
interventional
158
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedJune 3, 2015
May 1, 2015
8 months
June 1, 2015
June 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Corneal staining test
12 weeks
Secondary Outcomes (7)
Corneal staining test
4, 8 weeks
Conjunctival staining
4, 8, 12 weeks
Corneal and Conjunctival staining sum Score
4, 8, 12 weeks
Ocular surface disease index (OSDI)
4, 8, 12 weeks
Tear break up time (TBUT)
4, 8, 12 weeks
- +2 more secondary outcomes
Study Arms (2)
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
EXPERIMENTALCYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes
Restasis eye drop
ACTIVE COMPARATORRestasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes
Interventions
1 drop twice/day for 12 weeks to both eyes.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 3, 2015
Study Start
January 1, 2014
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
June 3, 2015
Record last verified: 2015-05