NCT02461719
Completed
Phase 3
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.
ConditionsDry Eye Syndromes
Overview
- Phase
- Phase 3
- Intervention
- CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
- Conditions
- Dry Eye Syndromes
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Corneal staining test
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Restasis eye drop
Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes
Intervention: Restasis
Outcomes
Primary Outcomes
Corneal staining test
Time Frame: 12 weeks
Secondary Outcomes
- Tear break up time (TBUT)(4, 8, 12 weeks)
- Non-anesthetic Schirmer test(4, 8, 12 weeks)
- 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)
- Frequency of concurrent drug use(4, 8, 12 weeks)
Study Sites (1)
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