NCT00831662

Brief Summary

The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, 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
490

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 9, 2015

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

January 27, 2009

Last Update Submit

December 21, 2014

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.

    6 weeks

Secondary Outcomes (1)

  • Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)

    6 weeks

Study Arms (2)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Arm 1

EXPERIMENTAL
Drug: Diquafosol tetrasodium ophthalmic solution, 2%

Interventions

Diquafosol tetrasodium ophthalmic solution, 2%DRUG

One to two drops in each eye QID for 6 weeks

Arm 1
PlaceboDRUG

One to two drops in each eye QID for 6 weeks

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Have best corrected visual acuity in both eyes of at least +0.7 or better
  • Central corneal staining of 3 on the NEI scale
  • If female, are non-pregnant or non-lactating
  • Have a history of dry eye disease in both eyes
  • Have normal lid anatomy

You may not qualify if:

  • Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
  • Have had ocular surface surgery within the past year
  • Are considered legally blind in one eye
  • Have a serious medical condition which could confound study assessments

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

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Reza Haque, MD, PhD

    Medical Monitor, Inspire

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 29, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 9, 2015

Record last verified: 2014-12