NCT00721656

Brief Summary

To evaluate the efficacy and safety of KLS-0611 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
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
Last Updated

March 18, 2009

Status Verified

March 1, 2009

First QC Date

July 22, 2008

Last Update Submit

March 16, 2009

Conditions

Dry Eye Syndromes

Keywords

Dry eye syndromesCorneal diseasesConjunctival Diseases

Outcome Measures

Primary Outcomes (1)

  • Corneal-conjunctival staining

    4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

KLS-0611

EXPERIMENTAL
Drug: KLS-0611

Interventions

PlaceboDRUG
Placebo
KLS-0611DRUG
KLS-0611

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
  • 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 (5)

Japan

Hokkaido Region, Japan

Location

Japan

Kansai Region, Japan

Location

Japan

Kanto Region, Japan

Location

Japan

Kyushu Region, Japan

Location

Japan

Shikoku Region, Japan

Location

MeSH Terms

Conditions

Dry Eye SyndromesCorneal DiseasesConjunctival Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Yasuhiro Omori

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Last Updated

March 18, 2009

Record last verified: 2009-03

Locations

JP(5)