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

Not Applicable

Completed

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0006070
• Lead Sponsor: Gachon University Gil Medical Center

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-03
• Last Update Posted: 22 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OSDI score

Secondary Outcome Measures

Name	Time	Method
Tear-film break up time;Grading of meibomian gland dysfunction