NCT00284999

Brief Summary

To determine the ocular efficacy and safety of Soothe and Refresh Tears.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

August 22, 2006

Status Verified

August 1, 2006

First QC Date

January 31, 2006

Last Update Submit

August 21, 2006

Conditions

Dry Eye Syndromes

Interventions

SootheDRUG
Refresh TearsDRUG

Eligibility Criteria

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

You may qualify if:

  • adults with a diagnosis of dry eyes
  • Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye
  • a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test

You may not qualify if:

  • contact lens use during the active treatment periods of the trial
  • history of Sjogren's Syndrome
  • temporary punctal occlusion that is still effective
  • the current or anticipated use during the study of punctual plugs
  • current treatment with Restasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Coastal Research Associates, LLC

Atlanta, Georgia, 30339, United States

Location

Michigan Cornea Associates

Southfield, Michigan, 48034, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • William C. Stewart, MD

    Pharmaceutical Research Network, LLC

    STUDY DIRECTOR

  • Penny Asbell, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Christopher Chow, MD

    Michigan Cornea Associates

    PRINCIPAL INVESTIGATOR

  • Douglas G. Day, MD

    Coastal Research Associates, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Completion

August 1, 2006

Last Updated

August 22, 2006

Record last verified: 2006-08

Locations

US(3)