A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

NCT ID: NCT02503189

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye With Sjögren's Syndrome

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KCT-0809

Group Type EXPERIMENTAL

KCT-0809 ophthalmic solution

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KCT-0809 ophthalmic solution

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Severe ophthalmic disorder
* Punctal plugs or surgery for occlusion of the lacrimal puncta
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokyo and Other Japanese City, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KCT1301

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome
NCT07185139 NOT_YET_RECRUITING EARLY_PHASE1
Study of TOP1630 for Dry Eye Syndrome
NCT03833388 COMPLETED PHASE2/PHASE3
A Study of AG-80308 in Dry Eye Patients
NCT05372107 COMPLETED PHASE1