NCT00037661

Brief Summary

Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2002

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

April 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

May 18, 2002

Last Update Submit

October 1, 2015

Conditions

Keratoconjunctivitis Sicca

Keywords

dry eye

Interventions

INS365 Ophthalmic SolutionDRUG

Eligibility Criteria

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

You may qualify if:

  • have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months
  • had intermittent or regular artificial tear use within past 3 months

You may not qualify if:

  • had LASIK surgery
  • had punctal occlusion or cauterization within last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconjunctivitis SiccaDry Eye Syndromes

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesLacrimal Apparatus 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

May 18, 2002

First Posted

May 20, 2002

Study Start

April 1, 2002

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

October 2, 2015

Record last verified: 2015-10