Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

April 16, 2018 updated by: Santen Inc.

A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.

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.

Detailed Description

This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.

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.
91

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
      • Newport Beach, California, United States, 92663
    • Georgia
      • Morrow, Georgia, United States, 30260
    • Missouri
      • Kansas City, Missouri, United States, 64133
    • New York
      • Rochester, New York, United States, 14618
    • Ohio
      • Cleveland, Ohio, United States, 44115
    • Texas
      • Austin, Texas, United States, 78731
      • San Antonio, Texas, United States, 78240

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
  • Qualifying intraocular pressure in at least one eye at Baseline
  • Qualifying corrected ETDRS visual acuity in each eye
  • Qualifying central cornea thickness in each eye

Main Exclusion Criteria:

  • Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
  • Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
  • Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
  • History of ocular surgery specifically intended to lower IOP
  • History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study
  • Intended or current use of any ocular medications other than study medications during the study
  • Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment
  • Known allergy or sensitivity to any components of the study medications
  • Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)
  • Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period
  • Females who are pregnant, nursing or planning a pregnancy

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

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: Group 1: DE-117 ophthalmic solution
One drop DE-117 Low Dose in each eye daily for 28 days
Drug: DE-117 ophthalmic solution
Experimental: Group 2: DE-117 ophthalmic solution
One drop DE-117 Low Middle Dose in each eye daily for 28 days
Drug: DE-117 ophthalmic solution
Experimental: Group 3: DE-117 ophthalmic solution
One drop DE-117 High Middle Dose in each eye daily for 28 days
Drug: DE-117 ophthalmic solution
Experimental: Group 4: DE-117 ophthalmic solution
One drop DE-117 High Dose in each eye daily for 28 days
Drug: DE-117 ophthalmic solution
Active Comparator: latanoprost ophthalmic solution
One drop latanoprost 0.005% in each eye daily for 28 days
Drug: latanoprost ophthalmic solution
Placebo Comparator: placebo (vehicle of DE-117) ophthalmic solution
One drop DE-117 vehicle in each eye once daily for 28 days
Other: Placebo

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
Measure Description
Time Frame
Intraocular pressure (mmHg)
Time Frame: Day 1, Day 8, Day 15 and Day 29
Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry
Day 1, Day 8, Day 15 and Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Day 1, Day 8, Day 15 and Day 29
Adverse events will be assessed at each visit to evaluate safety
Day 1, Day 8, Day 15 and Day 29
Ocular signs and symptoms
Time Frame: Day 1, Day 8, Day 15 and Day 29
Ocular symptoms and ocular signs will be collected at each visit using slit lamp biomicroscopy, dilated ophthalmoscopy, gonioscopy, automated perimetry visual field testing, corrected visual acuity and pachymetry
Day 1, Day 8, Day 15 and Day 29

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.
May 1, 2013

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.
August 1, 2013

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.
September 1, 2013

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).
May 29, 2013

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.
May 29, 2013

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.
June 4, 2013

Study Record Updates

Last Update Posted (Actual)

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.
April 18, 2018

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.
April 16, 2018

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.
April 1, 2018

More Information

Terms related to this study

Keywords

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.
  • 33-002

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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