Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Kissei

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: Placebo; Drug: KLS-0611

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721656

KLS1201

Details and patient eligibility

About

To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.

Enrollment: 80 estimated patients

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: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

KLS-0611

Experimental group

Treatment:

Drug: KLS-0611