NCT01211951

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

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

September 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

First QC Date

September 26, 2010

Last Update Submit

June 30, 2011

Conditions

Dry Eye Syndromes

Keywords

Dry eye syndromesCorneal diseasesConjunctival diseases

Outcome Measures

Primary Outcomes (1)

  • Corneal-conjunctival staining scores

    4 weeks

Study Arms (4)

KCT-0809 ophthalmic solution, low dose

EXPERIMENTAL
Drug: KCT-0809

KCT-0809 ophthalmic solution, medium dose

EXPERIMENTAL
Drug: KCT-0809

KCT-0809 ophthalmic solution, high dose

EXPERIMENTAL
Drug: KCT-0809

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

KCT-0809DRUG
KCT-0809 ophthalmic solution, low dose
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Corneal and conjunctival damage
  • Insufficiency of lacrimal secretion or tear film instability
  • 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)

Japan

Tohoku, Kanto, Chubu, Kansai, Kyushu Region, Japan

Location

MeSH Terms

Conditions

Dry Eye SyndromesCorneal DiseasesConjunctival Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Katsumi Hontani

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2010

First Posted

September 30, 2010

Last Updated

July 4, 2011

Record last verified: 2011-06

Locations

JP(1)