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

Dry Eye With Sjögren's Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503189
• Other study ID #: KCT1301
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2015
• Last updated: May 15, 2017

Study information

• Verified date: May 2017
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2017
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Dry Eye With Sjögren's Syndrome
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• KCT-0809 ophthalmic solution

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the corneal staining		12 weeks
Secondary	Score of the conjunctival staining		12 weeks