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

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

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

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

Source of Monetary/Material Support1
- Organization Name	Hanlim Pharmaceutical
- Organization Type	Pharmaceutical Company
- Project ID

Sponsor Organization

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

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

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

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 -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

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

Result Registerd	Yes Results Upload
Final Enrollment Number	24
Number of Publication	0
Results Upload	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

Sharing Statement	No