NCT01027013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

December 4, 2009

Last Update Submit

January 9, 2012

Conditions

Dry Eye SyndromesKeratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (2)

  • Total fluorescein corneal staining score

    4 weeks

  • Primary ocular discomfort

    4 weeks

Secondary Outcomes (2)

  • Dry eye symptoms

    12 weeks

  • Ocular staining

    12 weeks

Study Arms (2)

rebamipide 2% ophthalmic suspension

EXPERIMENTAL
Drug: rebamipide 2% ophthalmic suspension

Placebo eye drops

PLACEBO COMPARATOR
Drug: placebo eye drops

Interventions

rebamipide 2% ophthalmic suspensionDRUG

Instill one drop in each eye four times daily for 12 weeks.

rebamipide 2% ophthalmic suspension
placebo eye dropsDRUG

Instill one drop in each eye four times daily for 12 weeks.

Placebo eye drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Diagnosis of dry eye as defined by the protocol

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Eye Care Group, P.C.

Waterbury, Connecticut, 06708, United States

Location

Richard Eiferman, MD

Louisville, Kentucky, 40205, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Ora, Inc

Andover, Massachusetts, 01810, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesKeratoconjunctivitis Sicca

Interventions

rebamipide

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesKeratoconjunctivitisConjunctivitisConjunctival DiseasesKeratitisCorneal Diseases

Study Officials

  • Nancy Boman, MD, PhD

    Kubota Vision Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 7, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

US(5)