search
Back to results

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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DE-110 ophthalmic suspension high dose
DE-110 ophthalmic suspension low dose
Placebo
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DE-110 ophthalmic suspension high dose

DE-110 ophthalmic suspension low dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of DE-110

Secondary Outcome Measures

Individual Response Rate
Individual Efficacy
Individual Symptoms

Full Information

First Posted
November 9, 2010
Last Updated
May 19, 2014
Sponsor
Santen Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01239069
Brief Title
Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DE-110 ophthalmic suspension high dose
Arm Type
Experimental
Arm Title
DE-110 ophthalmic suspension low dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DE-110 ophthalmic suspension high dose
Intervention Description
ophthalmic suspension; high dose; QID
Intervention Type
Drug
Intervention Name(s)
DE-110 ophthalmic suspension low dose
Intervention Description
ophthalmic suspension; low dose; QID
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
DE-110 ophthalmic suspension vehicle;QID
Primary Outcome Measure Information:
Title
Efficacy of DE-110
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Individual Response Rate
Time Frame
12 weeks
Title
Individual Efficacy
Time Frame
12 weeks
Title
Individual Symptoms
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Inglewood
State/Province
California
Country
United States
City
Newport Beach
State/Province
California
Country
United States
City
Petaluma
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Bloomfield
State/Province
Connecticut
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Brooksville
State/Province
Florida
Country
United States
City
Largo
State/Province
Florida
Country
United States
City
Rosewell
State/Province
Georgia
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Bangor
State/Province
Maine
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs