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

Kissei

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: KCT-0809; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427816

KCT1202

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

KCT-0809 ophthalmic solution, low dose

Experimental group

Treatment:

Drug: KCT-0809

Drug: KCT-0809

KCT-0809 ophthalmic solution, high dose

Experimental group

Treatment:

Drug: KCT-0809

Drug: KCT-0809

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo