Topical Cyclosporine and Disease Progression

September 23, 2008 updated by: Innovative Medical
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60641
        • Lakeside Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild to Moderate dry eye symptoms

Exclusion Criteria:

  • Current use of Restasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2.
Drug: Endura
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
Active Comparator: 1.
Drug: Restasis
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Severity
Time Frame: 1 yr
1 yr

Secondary Outcome Measures

Outcome Measure
Time Frame
Staining
Time Frame: 1 yr
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Medical

Investigators

  • Principal Investigator: Sanjay Rao, Lakeside Eye Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 23, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13717A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Disease Progression

Clinical Trials on Restasis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe