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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2021/02/15
    • Registered Date : 2021/04/07
    • Last Updated Date : 2021/02/15
Background Information
1.Background  
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
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
Contact Details
3.Contact Details  
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 
Status
4. Status Status  
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
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Hanlim Pharmaceutical 
- Organization Type Pharmaceutical Company  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Gachon University Gil Medical Center 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
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.  
Study Design 정보
8. Study Design  
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 
Subject Eligibility Information
9. Subject  
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
-Adults over 19 years of age
-Patients diagnosed with meibomian gland dysfunction
-Patients with tear film destruction time of 8 seconds or less
-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
-Patients being treated with anti-inflammatory therapy for dry eye syndrome, such as steroid eye drops or non-steroidal anti-inflammatory eye drops
-Patients taking systemic steroids and immunosuppressants
-Patients with a history of ocular surgery within the last 6 months
-Patients who wear contact lenses during the clinical study
-Pregnant and lactating women
-Patients with a history of using cyclosporine eyedrops within the last 2 weeks
-Those whose intraocular pressure exceeds 25mmHg
-Punctal occlusion was performed within the last 1 month or during the clinical trial participation period
-Hypersensitivity reaction or suspicion of hypersensitivity to the ingredients of the clinical trial drug
-When the researcher determines that participation is inappropriate
-Patients with active ocular infection  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd Yes
Results Upload
Final Enrollment Number 24
Number of Publication
Results Upload Results Donwload 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.  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No