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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00721656
• Collaborator: (none)
• Enrollment: 80
• Locations: 5
• Arms: 2
• Patients Per Site: 16

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Placebo; Drug: KLS-0611	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: KLS-0611	Drug: KLS-0611

Outcome Measures

Primary Outcome Measures

1. Corneal-conjunctival staining [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

• 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	Hokkaido region		Japan
2	Japan	Kansai region		Japan
3	Japan	Kanto region		Japan
4	Japan	Kyushu region		Japan
5	Japan	Shikoku region		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

• Study Director: Yasuhiro Omori, Kissei Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00721656
• Other Study ID Numbers: KLS1201
• First Posted: Jul 24, 2008
• Last Update Posted: Mar 18, 2009
• Last Verified: Mar 1, 2009

• 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 Mar 18, 2009