A Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome

A Randomized, Double Blind, Placebo Controlled, Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01427816

Enrollment

180

Registered

2011-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry eye syndromes, Corneal diseases, Conjunctival diseases

Brief summary

To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.

Interventions

DRUGKCT-0809

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Severe ophthalmic disorder * Punctual plugs or surgery for occlusion of the lacrimal puncta

Design outcomes

Primary

Measure	Time frame
Corneal staining score	6 weeks

Secondary

Measure	Time frame
Conjunctival staining score	6 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026