NCT00549289

Brief Summary

The purpose of this phase III, open-label study is to determine the safety and tolerability 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

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

October 24, 2007

Last Update Submit

October 24, 2007

Conditions

Interventions

Eligibility Criteria

Age2 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of dry eye syndrome

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 study
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clayton Eye Center

Morrow, Georgia, 30260, 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

    Sirion Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations