NCT00679718

Brief Summary

To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2000

Shorter than P25 for phase_2

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, 2000

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2000

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

May 15, 2008

Last Update Submit

August 26, 2015

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (6)

  • Schirmer scores

  • Corneal staining

  • Conjunctival staining

  • Tear break-up time

  • Change in artificial tear usage

  • Patient-reported improvement of foreign body sensation

Secondary Outcomes (6)

  • Visual acuity

  • Investigator global severity assessment

  • Patient-reported dry eye symptoms other than foreign body sensation

  • Biomicroscopy

  • Ophthalmoscopy

  • +1 more secondary outcomes

Interventions

diquafosol tetrasodium (INS365) ophthalmic solutionDRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Best corrected visual acuity of at least +0.7 ETDRS
  • Six month history of dry eye disease
  • Mild severity in two out of five symptoms
  • Unanesthetized Schirmer score of less than or equal to 7mm
  • Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

You may not qualify if:

  • Nasal stimulated Schirmer score of less than 3mm
  • Have ongoing ocular infection
  • Have congenitally absent meibomian or lacrimal glands
  • Have had punctal occlusion within a specified time prior to study
  • Wear contact lens and refuse to remove them
  • Have other excluded eye conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Clinical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

January 1, 2000

Primary Completion

July 1, 2000

Study Completion

July 1, 2000

Last Updated

August 27, 2015

Record last verified: 2015-08