NCT00243711

Brief Summary

The efficacy, safety and acceptability of an investigational lubricant eye drop in subjects with dry eye will be evaluated in comparison with currently-available lubricant eye drops.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

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

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

7 months

First QC Date

October 21, 2005

Last Update Submit

May 27, 2011

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Dry Eye Symptoms

Secondary Outcomes (1)

  • Ocular surface damage, tear stability, tear production

Interventions

Carboxymethylcellulose sodium and GlycerinDRUG

Eligibility Criteria

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

You may qualify if:

  • Mild, Moderate, or Severe Dry Eye Symptoms and current eye drop use;
  • Reduced tear stability or tear production

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Warrensburg, Missouri, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Carboxymethylcellulose SodiumGlycerol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydratesTriose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic Chemicals

Study Officials

  • Mark Curtis, O.D.

    InSight Eyecare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 25, 2005

Study Start

September 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

US(1)