Comparative clinical study of eye drops in dry eye syndrome

A multicenter clinical trial to evaluate the efficacy, safety and usability of cyclosporine ophthalmic nanoemulsion 0.05% compared with cyclosporine ophthalmic emulsion 0.1%

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004516

Enrollment

Registered

2019-12-09

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-12-16

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

Conditions

None listed

Interventions

Drug : 1 Cyporinen Eye Drops 0.05&#37

: 0.5 mg/mL of cyclosporine 2 Ikervis Eye Drops 0.1&#37

: Cyclosporine 1.0 mg/mL Assigned to two groups of Dry Eye syndrome patients (KCDSG guidelines) of 0.05&#37

cyphorine and 0.1&#37

ikervis, regardless of age or gender 1) Cyporinen : Once, twice a day, once, 0.4mL/tube 2) Ikervis: Once a day, once a day, 0.3mL/tube 3) Since previous studies have reported that each drug has suf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult men and women over the age of 19 2) KCDSG guidelines diagnosed with dry eyes with moderate or higher levels (1) Cornea dye score NEI = 3 points or (2) TBUT =10 sec 3) Patients who can be monitored for at least 3 months 4) Those who understand this clinical trial and voluntarily agree to it in writing

Exclusion criteria

Exclusion criteria: 1) In case ophthalmic cyclosporin preparation is used by the person currently in use or within the last month 2) Persons with active eye infection such as Stevens-Johnson syndrome 3) A person with a past history of corneal transplantation or neuronutitis 4) Those with eye failure or condition that may affect the analysis of the research result, or those with history phobiasis, conjunctival scarring caused by semisplastic cornea, sclerosis, lack of serous tear glands, conjunctivitis, corneal esophageal force, etc. 5) Those who are overreacting to the ingredients (cyclosporin) of the clinical trial 6) Pregnant or nursing mothers

Design outcomes

Primary

Measure	Time frame
keratoconjunctival staining score	—

Secondary

Measure	Time frame
tear break up time;schirmer test	—

Countries

Korea, Republic of

Contacts

Public ContactChul Young Choi

Kangbuk Samsung Medical Center

sashimi0@naver.com+82-2-2001-2250

Outcome results