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Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

Primary Purpose

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rebamipide 2% ophthalmic suspension
placebo eye drops
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Eye Care Group, P.C.
  • Richard Eiferman, MD
  • Central Maine Eye Care
  • Ora, Inc
  • Total Eye Care, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rebamipide 2% ophthalmic suspension

Placebo eye drops

Arm Description

Outcomes

Primary Outcome Measures

Total fluorescein corneal staining score
Primary ocular discomfort

Secondary Outcome Measures

Dry eye symptoms
Ocular staining

Full Information

First Posted
December 4, 2009
Last Updated
January 9, 2012
Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01027013
Brief Title
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Keratoconjunctivitis Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rebamipide 2% ophthalmic suspension
Arm Type
Experimental
Arm Title
Placebo eye drops
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rebamipide 2% ophthalmic suspension
Intervention Description
Instill one drop in each eye four times daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo eye drops
Intervention Description
Instill one drop in each eye four times daily for 12 weeks.
Primary Outcome Measure Information:
Title
Total fluorescein corneal staining score
Time Frame
4 weeks
Title
Primary ocular discomfort
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Dry eye symptoms
Time Frame
12 weeks
Title
Ocular staining
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Boman, MD, PhD
Organizational Affiliation
Kubota Vision Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Eye Care Group, P.C.
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Richard Eiferman, MD
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Central Maine Eye Care
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Ora, Inc
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

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