Prospective clinical trial to evaluate efficacy, safety and usability of nanoemulsion cyclosporin 0.05%, emulsion cyclosporin 0.05% and diquafosol 3% in dry eye patients

A multicenter, randomized, partial double blind, active control, parallel clinical trial to evaluate the efficacy, safety and usability of cyclosporin ophthalmic nanoemulsion 0.05% compared with cyclosporin ophthalmic emulsion 0.05% and diquafosol ophthalmic solution 3%

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002180

Enrollment

227

Registered

2016-12-23

Start date

2016-10-21

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

None listed

Interventions

Drug : 3 arms (1st arm) Nanoemulsion cyclosporine 0.05&#37

ophthalmic soln. treatment arm: CYPORIN®N 0.05&#37

, 1 drop/time, 2 times/day, 12 weeks, ophthalmic (2nd arm) Emulsion cyclosporine 0.05&#37

ophthalmic soln. treatment arm: RESTASIS® 0.05&#37

, 1 drop/time, 2 times/day, 12 weeks, ophthalmic (3rd arm) Diquafosol tetrasodium ophthalmic soln. treatment arm: Diquas® 3&#37

, 1 drop/time, 6 times/day, 12 weeks, ophthalmic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) =19 years of age 2) moderate to severe Dry eye syndrome (Corneal BFS score(NEI scale) = 4 and = 10 sec on TBUT) 3) volentary agreement with signed informed consent

Exclusion criteria

Exclusion criteria: 1. cyclosporine or diquafosol use in any form(systemic, topical) within 4 weeks 2. medical condition or history within 4 weeks to be treated with topical agents besides artifical tears(glaucoma, ocular allergy, ocular inflammation/infectious disease, etc) 3. new start or medication change within 4 weeks for systemic drugs with probable effect on dry eye codition 4. sjogren syndrome 5. plan to wear contact lens during the study period 6. current or history of ocular disorders possibly affecting the study results(ocular surgery, trauma, diseases) 1) entropion, blepharelosis, blepharoplegia 2) ocular surgery history within 4 weeks or plan during the study period like punctal plug, punctal closure etc 3) herpetics keratopathy, conjunctival scarring by cicatricial keratoconjunctivitis, pterygium, congenital lacrimal gland shortage, neurogenic keratitis, keratoconus, corneal transplantation 7. known hypersensitivity to study medications 8, pregnancy or lactation 9. investigator's judge of inappropiation

Design outcomes

Primary

Measure	Time frame
Changes in corneal conjunctival staining score	—

Secondary

Measure	Time frame
Changes in corneal conjunctival staining score ;Changes in corneal staining score;Changes in conjunctival staining score;Changes in TBUT (tear break-up time);Changes in schirmer I test score ;Changes in OSDI(ocular surface disease index);Patient global evalution;tear mucin level change [exploratory endpoint];tear cytokine level change [exploratory endpoint]	—

Countries

Korea, Republic of

Contacts

Public ContactHyun-Seung Kim

The Catholic University of Korea, Yeouido St. Mary's Hospital

sergio6365@gmail.com+82-2-3779-1848

Outcome results