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A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02503189
Enrollment
Unknown
Registered
2015-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2017-05-17

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

Conditions

Dry Eye With Sjögren's Syndrome

Keywords

Dry eye syndromes, Corneal diseases, Conjunctival diseases

Brief summary

The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome

Interventions

DRUGKCT-0809 ophthalmic solution
DRUGPlacebo

Sponsors

Kissei Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

Inclusion criteria

* Dry eye patients with Sjögren's syndrome * Corneal and conjunctival damage

Exclusion criteria

* Severe ophthalmic disorder * Punctal plugs or surgery for occlusion of the lacrimal puncta

Design outcomes

Primary

MeasureTime frame
Score of the corneal staining12 weeks

Secondary

MeasureTime frame
Score of the conjunctival staining12 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026