NCT01890941

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

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

June 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

First QC Date

June 27, 2013

Last Update Submit

October 16, 2015

Conditions

Dry Eye Syndromes

Keywords

Dry eye syndromesCorneal diseasesConjunctival diseases

Outcome Measures

Primary Outcomes (1)

  • Score of the Corneal conjunctival staining

    8weeks

Secondary Outcomes (1)

  • Incidences of Adverse Events

    8weeks

Study Arms (3)

KCT-0809 Lower Dose

EXPERIMENTAL
Drug: KCT-0809 ophthalmic solution

KCT-0809 Higher Dose

EXPERIMENTAL
Drug: KCT-0809 ophthalmic solution

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KCT-0809 ophthalmic solutionDRUG
KCT-0809 Higher DoseKCT-0809 Lower Dose
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Corneal and conjunctival damage
  • Insufficiency of lacrimal secretion
  • Ocular symptom

You may not qualify if:

  • Severe ophthalmic disorder
  • Punctual 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 2
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 2, 2013

Primary Completion

March 1, 2014

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

JP(1)