NCT00502073

Brief Summary

The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

First QC Date

July 13, 2007

Last Update Submit

June 29, 2011

Conditions

Interventions

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

You may not qualify if:

  • Intraocular or refractive surgery in the study eye within 3 months prior to study start
  • Unwilling to discontinue use of contact lenses during the run-in and duration of the study
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Center Northeast

Bangor, Maine, 04401, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Roger Vogel, MD

    Sirion Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 17, 2007

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations