A Study of KCT-0809 in Patients With Dry Eye Syndromes

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01211951
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: KCT-0809; Drug: KCT-0809; Drug: KCT-0809; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Placebo Controlled, Exploratory Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KCT-0809 ophthalmic solution, low dose	Drug: KCT-0809
Experimental: KCT-0809 ophthalmic solution, medium dose	Drug: KCT-0809
Experimental: KCT-0809 ophthalmic solution, high dose	Drug: KCT-0809
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Corneal-conjunctival staining scores [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Corneal and conjunctival damage

• Insufficiency of lacrimal secretion or tear film instability

• Ocular symptom

Exclusion Criteria:

• Severe ophthalmic disorder

• Punctual plugs or surgery for occlusion of the lacrimal puncta

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Japan	Tohoku, Kanto, Chubu, Kansai, Kyushu region		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

• Study Director: Katsumi Hontani, Kissei Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01211951
• Other Study ID Numbers: KCT1201
• First Posted: Sep 30, 2010
• Last Update Posted: Jul 4, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Dry eye syndromes; Corneal diseases; Conjunctival diseases
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome

Study Results

No Results Posted as of Jul 4, 2011