NCT00403975

Brief Summary

The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
640

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3

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

June 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

November 22, 2006

Last Update Submit

February 19, 2016

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Change in dry eye testing measures

Secondary Outcomes (1)

  • Change in dry eye testing measures and symptoms

Interventions

diquafosol tetrasodium ophthalmic solution, 2%DRUG

Eligibility Criteria

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

You may qualify if:

  • best corrected visual acuity in both eyes of at least +0.7
  • six-month documented history of dry eye disease
  • as least mild severity in 1 of the 5 dry eye symptoms
  • corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15)

You may not qualify if:

  • permanent conjunctival goblet cell loss or scarring conditions
  • ongoing contact lens wear
  • current topical ophthalmic medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 27, 2006

Study Start

June 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

February 22, 2016

Record last verified: 2016-02