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  • Status : Approved
    • First Submitted Date : 2021/02/15
    • Registered Date : 2021/04/07
    • Last Updated Date : 2021/02/15
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1. Background

Background Information
CRIS
Registration Number
KCT0006070 
Unique Protocol ID GBIRB2016-238 
Public/Brief Title The comparison of the therapeutic effects between 0.05% Tsporin and 0.05% Restasis in meibomian gland dysfunction 
Scientific Title The comparison of the therapeutic effects between 0.05% Tsporin and 0.05% Restasis in meibomian gland dysfunction  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number GBIRB2016-238 
Approval Date 2016-08-30 
Institutional Review Board  
Name Institutional Review Board of Gil Medical Center 
Address 21, Namdong-daero 774beon-gil, Namdong-gu, Incheon 
Telephone 032-460-2092 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Dong Hyun Kim 
Title Assistant professor 
Telephone +82-32-460-3364 
Affiliation Gachon University Gil Medical Center 
Address Gil Medical Center, Gachon University College of Medicine, 1198, Guwol-dong, Namdong-Gu, Incheon 
Contact Person for Public Queries
Name Dong Hyun Kim 
Title Assistant professor 
Telephone +82-32-460-3364 
Affiliation Gachon University Gil Medical Center 
Address Gil Medical Center, Gachon University College of Medicine, 1198, Guwol-dong, Namdong-Gu, Incheon 
Contact Person for Updating Information
Name Dong Hyun Kim 
Title Assistant professor 
Telephone +82-32-460-3364 
Affiliation Gachon University Gil Medical Center 
Address Gil Medical Center, Gachon University College of Medicine, 1198, Guwol-dong, Namdong-Gu, Incheon 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2016-08-30 , Actual
Target Number of Participant 50
Primary Completion Date 2019-03-27 , Actual
Study Completion Date 2019-12-03 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Gachon University Gil Medical Center 
Recruitment Status Completed  
Date of First Enrollment 2016-08-30 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Hanlim Pharmaceutical 
Organization Type Pharmaceutical Company  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Gachon University Gil Medical Center 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Topical cyclosporin is known to be effective in patients with meibomian gland dysfunction. Restasis, well-known cyclosporine eyedrop, is a suspension type component, so the burning sensation is the biggest issue that decrease patient compliance. Tsporin ophthalmic solution, which is made via nano-emulsion technique, is expected to increase the solubility of cyclosporin and to improve the clinical effects more.

The purpose of this study was to compare the therapeutic efficacy between two cyclosporine eyedrops in patients with meibomian gland dysfunction.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Drug  
Intervention Description Ocular surface disease index (OSDI), meibomian gland dysfunction grading, corneal staining, tear film destruction time (TBUT), and tear secretion between Tsporin and restasis groups at 12 weeks compared to baseline parameters. Fumeron (0.1% Fluorometholone) was used 4 times a day for the initial 4 weeks of treatment for improving initial discomfort and drug compliance in all patients, and then randomly assigned to the Tsporin and Restasis group for an additional 8 weeks.  
Number of Arms
Arm 1 Arm Label Restasis group 
Target Number of Participant 25 
Arm Type Active comparator 
Arm Description Group treated with Restasis eyedrops Restasis eye drops 0.05% BID 
Arm 2 Arm Label Tsporin group 
Target Number of Participant 25 
Arm Type Experimental 
Arm Description Group treated with Tsporin eyedrops T Sporin Eye Drop 0.05% BID 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the eye and adnexa
 Meibomian gland dysfunction
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 99 Year
Description Inclusion criteria <br />-Adults over 19 years of age <br />-Patients diagnosed with meibomian gland dysfunction <br />-Patients with tear film destruction time of 8 seconds or less <br />-Patients who complain of one or more of the following symptoms related to tear film instability (foreign body sensation, glare, tears)  
Exclusion Criteria Exclusion criteria <br />-Patients being treated with anti-inflammatory therapy for dry eye syndrome, such as steroid eye drops or non-steroidal anti-inflammatory eye drops <br />-Patients taking systemic steroids and immunosuppressants <br />-Patients with a history of ocular surgery within the last 6 months <br />-Patients who wear contact lenses during the clinical study <br />-Pregnant and lactating women <br />-Patients with a history of using cyclosporine eyedrops within the last 2 weeks <br />-Those whose intraocular pressure exceeds 25mmHg <br />-Punctal occlusion was performed within the last 1 month or during the clinical trial participation period <br />-Hypersensitivity reaction or suspicion of hypersensitivity to the ingredients of the clinical trial drug <br />-When the researcher determines that participation is inappropriate <br />-Patients with active ocular infection  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome OSDI score 
Timepoint 12 weeks after treatments 
Secondary Outcome(s) 1 
Outcome Tear-film break up time 
Timepoint 12 weeks after treatments 
Secondary Outcome(s) 2 
Outcome Grading of meibomian gland dysfunction 
Timepoint 12 weeks after treatments 

11. Study Results and Publication

Study Results and Publication Information
Result Registered Yes
Results Upload
Final Enrollment Number 24
Number of Publication
Results Upload 연구결과 파일저장 Results Donwload  
Date of Posting Results 2021-04-07
Protocol URL or File Upload  
Brief Summary In patients with meibomian gland dysfunction, the use of low-concentration steroids (0.1% fluorometholone) for the initial 4 weeks and Tsporin or Restasis for the next 8 weeks revealed the improvement of OSDI score, TBUT, and MGD grading. Tsporin group showed somewhat better improvement in TBUT and corneal staining score at 12 weeks of treatment compared to baseline compared to the Restasis group.  

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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