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

Kissei

Status and phase: Completed; Phase 3

Conditions: Dry Eye With Sjögren's Syndrome

Treatments: Drug: KCT-0809 ophthalmic solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02503189

KCT1301

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

KCT-0809

Experimental group

Treatment:

Drug: KCT-0809 ophthalmic solution

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo