Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

November 1, 2011 updated by: Santen Inc.

Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease

The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 2
  • Phase 1

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
    • California
      • Inglewood, California, United States
      • Torrance, California, United States
    • Connecticut
      • Bloomfield, Connecticut, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • New Albany, Indiana, United States
    • Louisiana
      • Gretna, Louisiana, United States
    • Maine
      • Bangor, Maine, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • San Antonio, Texas, United States

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:

  • confirmed diagnosis of dry eye defined by protocol
  • 18 years or older, and sign written informed consent
  • negative pregnancy test and utilizing reliable contraceptive throughout study

Exclusion Criteria:

  • use of any topical ocular medications
  • any ocular surgery within 90 days of study
  • laser refractive surgery within one year of study
  • ocular, lid disease/abnormalities that may interfere with the study
  • corneal transplants
  • uncontrolled systemic conditions
  • females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
  • participated in another drug trial within 30 days prior to study

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DE-101 ophthalmic suspension high dose
Drug: DE-101 ophthalmic suspension
Ophthalmic suspention; QID
Drug: DE-101 ophthalmic suspension
Ophthalmic suspension; QID
Experimental: DE-101 ophthalmic suspension low dose
Drug: DE-101 ophthalmic suspension
Ophthalmic suspention; QID
Drug: DE-101 ophthalmic suspension
Ophthalmic suspension; QID
Placebo Comparator: DE-101 ophthalmic suspension vehicle
Drug: DE-101 ophthalmic suspension
Ophthalmic suspention; QID
Drug: DE-101 ophthalmic suspension
Ophthalmic suspension; QID
Drug: DE-101 ophthalmic suspension vehicle
ophthalmic suspension vehicle; QID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total fluorescein corneal staining
Time Frame: 8 weeks
8 weeks
Ocular Symptom Severity
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Santen Inc.

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

April 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

November 3, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-004

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.

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