Clinical trial NCT01632137: Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Official title: A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2012-07-02
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* History of dry eye-related ocular symptoms for at least 20 months.
* Meet protocol-defined criteria for corneal and conjunctival staining.
* Meet protocol-defined criteria for ocular discomfort.

Exclusion Criteria:

* Active anterior segment ocular disease other than dry eye syndrome.
* Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
* Inability to suspend the use of contact lenses for the duration of the study.
* Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
* Received any other investigational product within 4 months before the screening visit.

Primary outcomes:
measure: Primary ocular sign: Fluorescein corneal staining total score
timeFrame: 4 weeks
measure: Primary ocular symptom: Worst ocular symptom severity score
timeFrame: 4 weeks
Secondary outcomes:
measure: Fluorescein corneal staining total score
timeFrame: 2 weeks
measure: Worst ocular symptom severity score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Artesia
country: United States
state: California
city: Glendale
country: United States
state: California
city: Inglewood
country: United States
state: California
city: San Diego
country: United States
state: California
city: Wheat Ridge
country: United States
state: Colorado
city: Fort Myers
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Morrow
country: United States
state: Georgia
city: Baton Rouge
country: United States
state: Louisiana
city: Lutherville
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Princeton
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Rockville Centre
country: United States
state: New York
city: Valley Stream
country: United States
state: New York
city: Wantagh
country: United States
state: New York
city: Ashville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Kubota Vision Inc.
name: Acucela Medical Monitor
role: STUDY_DIRECTOR
References: