Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease

May 19, 2014 updated by: Santen Inc.

A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease

Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

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
      • Newport Beach, California, United States
      • Petaluma, California, United States
      • Torrance, California, United States
    • Connecticut
      • Bloomfield, Connecticut, United States
    • Florida
      • Bradenton, Florida, United States
      • Brooksville, Florida, United States
      • Largo, Florida, United States
    • Georgia
      • Rosewell, Georgia, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maine
      • Bangor, Maine, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, 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
  • Not wear contact lenses during study
  • 18 years or older
  • Understand and provide written consent
  • Negative pregnancy test and use acceptable method of contraception

Exclusion Criteria:

  • Use of any topical ocular medication
  • Any type of ocular surgery
  • Diagnosis of on-going ocular infection and/or allergic conjunctivitis
  • Uncontrolled systemic conditions/lid abnormalities
  • Corneal transplants
  • Females who are pregnant, nursing or planning a pregnancy
  • Participation in another drug trial concurrently or 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
DE-110 ophthalmic suspension vehicle;QID
Experimental: DE-110 ophthalmic suspension high dose
Drug: DE-110 ophthalmic suspension high dose
ophthalmic suspension; high dose; QID
Experimental: DE-110 ophthalmic suspension low dose
Drug: DE-110 ophthalmic suspension low dose
ophthalmic suspension; low dose; QID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of DE-110
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Individual Response Rate
Time Frame: 12 weeks
12 weeks
Individual Efficacy
Time Frame: 12 weeks
12 weeks
Individual Symptoms
Time Frame: 12 weeks
12 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

November 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30-002

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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