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

December 14, 2012 updated by: Santen Inc.

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

To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
183

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • New Port Beach, California, United States, 92663
    • Colorado
      • Parker, Colorado, United States, 80134
    • Florida
      • Largo, Florida, United States, 33773
    • Georgia
      • Morrow, Georgia, United States, 30260
      • Roswell, Georgia, United States, 30076
    • Maine
      • Bangor, Maine, United States, 04401
    • Missouri
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63131
      • Washington, Missouri, United States, 63090
    • North Carolina
      • High Point, North Carolina, United States, 27262
    • Ohio
      • Cleveland, Ohio, United States, 44115
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Norfolk, Virginia, United States, 23507

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals considered for entry into the study will be of either sex and any race who have:
  • a confirmed diagnosis of dry eye,
  • are willing to use no ocular treatments during the study other than study medication,
  • have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
  • will not use contact lenses during the study,
  • Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
  • 18 years of age or older,
  • able to understand and provide written informed consent

Exclusion Criteria:

  • Subjects with any of the following are not eligible to participate in the study:
  • Fluorescein corneal staining or conjunctival staining that is too severe
  • Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
  • Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
  • Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
  • Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
  • Ocular(including lid)disease/abnormality that may interfere with the study
  • Corneal transplant in either eye, at any time prior to enrollment in the study
  • Laser refractive surgery less than one year prior to Visit 1 (Day 1)
  • Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
  • Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
  • Known allergy or sensitivity to any of the study medication components
  • Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
  • A woman who is pregnant, nursing, or planning a pregnancy
  • Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DE-101 Ophthalmic Suspension High Dose
Drug: DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
Experimental: DE-101 Ophthalmic Suspension Low Dose
Drug: DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
Placebo Comparator: DE-101 Ophthalmic Suspension Vehicle
Drug: DE-101 Ophthalmic Suspension Vehicle
Ophthalmic suspension vehicle; QID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Tear volume increase from baseline
Time Frame: baseline and 6 months
baseline and 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-005

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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