- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02229955
Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease (HL_TSPR_302)
A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease
The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) 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.
- Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Seocho-Ku
-
Seoul, Seocho-Ku, Korea, Republic of, 137-701
- The Catholic University of Korea Seoul St. Mary'S Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
[Patients with moderate-to-severe ocular dry eye]
- The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
- Non-anesthetic Schirmer test value ≤ 10mm/5min patients at least one eye score (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye, Schirmer test value ≥ 3mm/5min)
- Tear break-up time is 10 seconds or less
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)
Exclusion Criteria:
- Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- Abnormal eyelid function : Disoders of the eyelids or eyelashes
- Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
- Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation
- current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- The use in clinical trials of drug hypersensitivity reactions in patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T-sporin eye drop
Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
|
1 drop twice/day for 12 weeks to both eyes
Other Names:
|
Active Comparator: Restasis eye drop
Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
|
1 drop twice/day for 12 weeks to both eyes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal staining test
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal staining test
Time Frame: 4, 8 weeks
|
4, 8 weeks
|
Ocular surface disease index (OSDI)
Time Frame: 4, 8, 12 weeks
|
4, 8, 12 weeks
|
Tear break up time (TBUT)
Time Frame: 4, 8, 12 weeks
|
4, 8, 12 weeks
|
Non-anesthetic Schirmer test
Time Frame: 4, 8, 12 weeks
|
4, 8, 12 weeks
|
Conjunctival staining
Time Frame: 4, 8, 12 weeks
|
4, 8, 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Eye Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Pharmaceutical Solutions
- Calcineurin Inhibitors
- Ophthalmic Solutions
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- HL_TSPR_302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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