NCT00680108

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients 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
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 1999

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

September 1, 1999

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
8 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

8 months

First QC Date

May 15, 2008

Last Update Submit

August 26, 2015

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (5)

  • Evaluation of adverse events

  • Ocular symptomatology

  • Visual acuity

  • Biomicroscopy

  • Ophthalmoscopy

Secondary Outcomes (1)

  • Unanesthetized Schirmer test

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 20/40 in each eye
  • out 5 specified symptoms
  • Corneal fluorescein staining score greater than or equal to 3 out of 15

You may not qualify if:

  • Unable to stop concomitant medications
  • Have had intraocular surgery in previous 90 days
  • Have excluded systemic or ocular disease
  • Wear contact lenses and are not willing to remove them
  • Have intraocular pressure greater than 22 mg Hg

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

September 1, 1999

Primary Completion

May 1, 2000

Study Completion

May 1, 2000

Last Updated

August 27, 2015

Record last verified: 2015-08