Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
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
1 other identifier
interventional
140
1 country
14
Brief Summary
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2010
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 9, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMay 21, 2014
May 1, 2014
11 months
November 9, 2010
May 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of DE-110
12 weeks
Secondary Outcomes (3)
Individual Response Rate
12 weeks
Individual Efficacy
12 weeks
Individual Symptoms
12 weeks
Study Arms (3)
DE-110 ophthalmic suspension high dose
EXPERIMENTALDE-110 ophthalmic suspension low dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
ophthalmic suspension; high dose; QID
ophthalmic suspension; low dose; QID
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of dry eye
- Not wear contact lenses during study
- years or older
- Understand and provide written consent
- Negative pregnancy test and use acceptable method of contraception
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Inc.lead
Study Sites (14)
Unknown Facility
Inglewood, California, United States
Unknown Facility
Newport Beach, California, United States
Unknown Facility
Petaluma, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Bloomfield, Connecticut, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Brooksville, Florida, United States
Unknown Facility
Largo, Florida, United States
Unknown Facility
Rosewell, Georgia, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Bangor, Maine, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2010
First Posted
November 11, 2010
Study Start
November 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
May 21, 2014
Record last verified: 2014-05