Clinical Trial on the Evaluation of Cyporin N Eye Drop for Dry Eye Patients with Meibomian Gland Dysfunction

Prospective, Single Center Study on Comparison of the Clinical Efficacy and Patients Satisfaction of Cyporin N 0.05% Eye Drops in Dry Eye Patients with meibomian gland dysfunction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004199

Enrollment

Registered

2019-08-14

Start date

2019-08-26

Completion date

Unknown

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients who voluntarily agreed to participate in the study are randomly assigned to one of two groups accoding to random number 1 (the experimental group) or 2 (the contol group) using the Exc

) is administered 4 times a day and eyelids warm compress is conducted twice a day for 10 minutes. In the control group, artificial tear drops (NewHyaluni0.15&#37

) is administered 6 times a day and eyelids warm compress is conducted twice a day for 10 minutes.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Subjects who visit Korea University Ansan Hospital during the study period and who diagnosed as dry eyes with meibomian gland dysfunction. -Subjects who voluntarily agreed to participate in the study -Subjects with symptoms of dry eyes with meibomian gland dysfunction at least 3 months -Subjects who have tear break-up time less than 5 seconds

Exclusion criteria

Exclusion criteria: - Under 20 years of age - History of using topical cyclosporine A, steroid, and antibiotic eye drops within 4 weeks of screening. - Subjects who wear contact lenses within 4 weeks of screening. - Subjects with ocular inflammation other than meibomian gland dysfunction and dry eyes - History of ophthalmologic surgery and ocular trauma within torce within 3 months of screening - Subjects who are planning to undergo eye surgery during the study period - Pregnant, lactating women and women who have a pregnancy plan within 26 weeks of screening - Those who have hypersensitivity to research medicines - Those who have allergic reactions to fluorescein or topical anesthetic - History of systemic use of tetracycline derivatives (antihistamine, isotretinoin) - Those judged by researchers to be unsuitable

Design outcomes

Primary

Measure	Time frame
Ocular Surface Disease Index (OSDI) score	—

Secondary

Measure	Time frame
Corneal staining score with fluorescein sodium, Tear break-up time, Anterior blepharitis grade, Meibomian Gland Dysfunction (MGD) grade, Schirmer test	—

Countries

Korea, Republic of

Contacts

Public ContactHee Young Kim

Korea University Ansan Hospital

letpooh00@naver.com+82-31-412-5168

Outcome results