12-week, multi-center, randomized, human body application test for the efficacy evaluation of rTG-Omega3 in dry eye disease accompanied by Meibomian Gland Dysfunction(MGD).

Not Applicable

Recruiting

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0008161
• Lead Sponsor: Taejoon Pharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. A person who has been diagnosed with Meibomian gland dysfunction (MGD) within 3 months(based on the latest surgery) of undergoing binocular cataract surgery(at least one of the three criteria below is satisfied).

1) During eyelid compression, the discharge of meibomian glands is reduced, showing cloudy, toothpaste-like secretions, or viscous secretions.
2) Two or more Telangiectasia on the edge of the eyelid.
3) Two or more Meibomian Glands Orfices are blocked

*Drugs/treatment materials used during cataract surgery are subject to institutional standards.

2 Those with a Tearfilm Break-Up Time (TBUT) of less than 10 seconds

3. A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.

Exclusion Criteria

- Those who are judged to be inappropriate to participate in this human application test under the judgment of nvestigators

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Tearfilm Break-up Time(TBUT)

Secondary Outcome Measures

Name	Time	Method
Tear Volume(Strip Meniscometry Tube)