Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo (vehicle)
|
Drug: Placebo (vehicle)
Instill one drop into each eye 4 times a day for 4 weeks.
|
| Experimental: Rebamipide 2% ophthalmic suspension
|
Drug: Rebamipide 2% ophthalmic suspension
Instill one drop into each eye 4 times a day for 4 weeks.
|
Outcome Measures
Primary Outcome Measures
- Primary ocular sign: Fluorescein corneal staining total score [4 weeks]
- Primary ocular symptom: Worst ocular symptom severity score [4 weeks]
Secondary Outcome Measures
- Fluorescein corneal staining total score [2 weeks]
- Worst ocular symptom severity score [2 weeks]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phoenix | Arizona | United States | ||
| 2 | Little Rock | Arkansas | United States | ||
| 3 | Artesia | California | United States | ||
| 4 | Glendale | California | United States | ||
| 5 | Inglewood | California | United States | ||
| 6 | San Diego | California | United States | ||
| 7 | Wheat Ridge | Colorado | United States | ||
| 8 | Fort Myers | Florida | United States | ||
| 9 | Miami | Florida | United States | ||
| 10 | Plantation | Florida | United States | ||
| 11 | Stuart | Florida | United States | ||
| 12 | Tampa | Florida | United States | ||
| 13 | Morrow | Georgia | United States | ||
| 14 | Baton Rouge | Louisiana | United States | ||
| 15 | Lutherville | Maryland | United States | ||
| 16 | Kansas City | Missouri | United States | ||
| 17 | Saint Louis | Missouri | United States | ||
| 18 | Washington | Missouri | United States | ||
| 19 | Las Vegas | Nevada | United States | ||
| 20 | Princeton | New Jersey | United States | ||
| 21 | Rochester | New York | United States | ||
| 22 | Rockville Centre | New York | United States | ||
| 23 | Valley Stream | New York | United States | ||
| 24 | Wantagh | New York | United States | ||
| 25 | Ashville | North Carolina | United States | ||
| 26 | Charlotte | North Carolina | United States | ||
| 27 | Cleveland | Ohio | United States | ||
| 28 | Mason | Ohio | United States | ||
| 29 | Pittsburgh | Pennsylvania | United States | ||
| 30 | Chattanooga | Tennessee | United States | ||
| 31 | Memphis | Tennessee | United States | ||
| 32 | Houston | Texas | United States | ||
| 33 | Salt Lake City | Utah | United States | ||
| 34 | Norfolk | Virginia | United States |
Sponsors and Collaborators
- Kubota Vision Inc.
- Otsuka Pharmaceutical Co., Ltd.
Investigators
- Study Director: Acucela Medical Monitor, Kubota Vision Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACU-RED-301