임상연구정보서비스

Search: Search

The comparison of the therapeutic effects between 0.05% Tsporin and 0.05% Restasis in meibomian gland dysfunction

Status Approved

First Submitted Date

2021/02/15
Registered Date

2021/04/07
Last Updated Date

2021/02/15

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
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
Institutional Review Board Address	21, Namdong-daero 774beon-gil, Namdong-gu, Incheon
Institutional Review Board Telephone	032-460-2092
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
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, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
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
Name of Study	Gachon University Gil Medical Center
Recruitment Status	Completed
Date of First Enrollment	2016-08-30 ,

5. Source of Monetary / Material Support

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

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
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.

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, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
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	2
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)	* (H00-H59)Diseases of the eye and adnexa (H04.11)Dry eye syndrome Meibomian gland dysfunction
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~99Year
	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

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
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, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Results Upload
Final Enrollment Number	24
Number of Publication	0
Results Upload	최종보고서 - 티스포린 20191113_가천의대 김동현.docx
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, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top

The comparison of the therapeutic effects between 0.05&#37; Tsporin and 0.05&#37; Restasis in meibomian gland dysfunction

The comparison of the therapeutic effects between 0.05% Tsporin and 0.05% Restasis in meibomian gland dysfunction