NCT00404131

Brief Summary

The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2001

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

March 1, 2001

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
5 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

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

November 22, 2006

Last Update Submit

November 28, 2016

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Change in dry eye testing measures and symptoms

Secondary Outcomes (1)

  • Change in dry eye testing measures and symptoms

Interventions

diquafosol tetrasodium (INS365) Ophthalmic SolutionDRUG

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
  • at least mild severity in 2 of the 4 dry eye symptoms
  • unanesthetized Schirmer score of less than or equal to 7mm
  • corneal fluorescein staining of greater than or equal to 4 (out of 15)

You may not qualify if:

  • nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
  • ongoing contact lens wear
  • current topical ophthalmic medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9.

    PMID: 15502479RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

diquafosolOphthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Amy Schaberg, BSN

    STUDY DIRECTOR

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

March 1, 2001

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

November 29, 2016

Record last verified: 2016-11