An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

Dry Eye With Sjögren's Syndrome Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02503176
• Other study ID #: KCT1302
• Status: Terminated
• Phase: Phase 3
• First received: July 17, 2015
• Last updated: March 2, 2018

Study information

• Verified date: March 2018
• 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 evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: May 29, 2017
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Dry eye patients with Sjögren's syndrome finished KCT1301 study

Exclusion Criteria:

• Patients with poor adherence to medication of study drug in KCT1301 study

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

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	Incidences of adverse events		52 weeks
Secondary	Score of the corneal staining		52 weeks