Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye
Sponsor
Kubota Vision Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01027013
Collaborator
Otsuka Pharmaceutical Co., Ltd. (Industry)
220
5
2
11
44
4
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)
Study Start Date
:
Dec 1, 2009
Actual Primary Completion Date
:
Oct 1, 2010
Actual Study Completion Date
:
Nov 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rebamipide 2% ophthalmic suspension
|
Drug: rebamipide 2% ophthalmic suspension
Instill one drop in each eye four times daily for 12 weeks.
|
| Placebo Comparator: Placebo eye drops
|
Drug: placebo eye drops
Instill one drop in each eye four times daily for 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- Total fluorescein corneal staining score [4 weeks]
- Primary ocular discomfort [4 weeks]
Secondary Outcome Measures
- Dry eye symptoms [12 weeks]
- Ocular staining [12 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 18 years and older
-
Diagnosis of dry eye as defined by the protocol
Exclusion Criteria:
-
Ongoing ocular disease that may interfere with study parameters.
-
Inability to stop using topical ophthalmic medications throughout the duration of the study
-
Inability to stop the use of contact lenses for the duration of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Eye Care Group, P.C. | Waterbury | Connecticut | United States | 06708 |
| 2 | Richard Eiferman, MD | Louisville | Kentucky | United States | 40205 |
| 3 | Central Maine Eye Care | Lewiston | Maine | United States | 04240 |
| 4 | Ora, Inc | Andover | Massachusetts | United States | 01810 |
| 5 | Total Eye Care, P.A. | Memphis | Tennessee | United States | 38119 |
Sponsors and Collaborators
- Kubota Vision Inc.
- Otsuka Pharmaceutical Co., Ltd.
Investigators
- Study Director: Nancy Boman, MD, PhD, Kubota Vision Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kubota Vision Inc.
ClinicalTrials.gov Identifier:
NCT01027013
Other Study ID Numbers:
- ACU-RED-203
First Posted:
Dec 7, 2009
Last Update Posted:
Jan 11, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms: