NCT02503189

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

First QC Date

July 17, 2015

Last Update Submit

May 15, 2017

Conditions

Dry Eye With Sjögren's Syndrome

Keywords

Dry eye syndromesCorneal diseasesConjunctival diseases

Outcome Measures

Primary Outcomes (1)

  • Score of the corneal staining

    12 weeks

Secondary Outcomes (1)

  • Score of the conjunctival staining

    12 weeks

Study Arms (2)

KCT-0809

EXPERIMENTAL
Drug: KCT-0809 ophthalmic solution

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KCT-0809 ophthalmic solutionDRUG
KCT-0809
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Conditions

Dry Eye SyndromesCorneal DiseasesConjunctival Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 20, 2015

Primary Completion

January 1, 2017

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

JP(1)