NCT00471419

Brief Summary

The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective treatment of dry eye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

July 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

June 5, 2012

Status Verified

March 1, 2008

Enrollment Period

1.1 years

First QC Date

May 7, 2007

Last Update Submit

June 3, 2012

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Corneal staining; dry eye sympton

    Immediate

Secondary Outcomes (1)

  • Corneal staining; dry eye sympton

    Prolonged

Interventions

RimexoloneDRUG

Eligibility Criteria

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

You may qualify if:

  • documented dry eye history
  • ocular symptoms
  • tear use
  • dry eye ocular signs

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland

Cleveland, Ohio, 44115, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

rimexolone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Michael Brubaker, PhD

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 9, 2007

Study Start

July 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

June 5, 2012

Record last verified: 2008-03

Locations

US(1)