Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
1 other identifier
interventional
132
1 country
10
Brief Summary
The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms 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_1
Started Apr 2010
Shorter than P25 for phase_1
10 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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 3, 2011
November 1, 2011
8 months
April 29, 2010
November 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total fluorescein corneal staining
8 weeks
Ocular Symptom Severity
8 weeks
Study Arms (3)
DE-101 ophthalmic suspension high dose
EXPERIMENTALDE-101 ophthalmic suspension low dose
EXPERIMENTALDE-101 ophthalmic suspension vehicle
PLACEBO COMPARATORInterventions
Ophthalmic suspention; QID
ophthalmic suspension vehicle; QID
Eligibility Criteria
You may qualify if:
- confirmed diagnosis of dry eye defined by protocol
- years or older, and sign written informed consent
- negative pregnancy test and utilizing reliable contraceptive throughout study
You may not qualify if:
- use of any topical ocular medications
- any ocular surgery within 90 days of study
- laser refractive surgery within one year of study
- ocular, lid disease/abnormalities that may interfere with the study
- corneal transplants
- uncontrolled systemic conditions
- females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- participated in another drug trial within 30 days prior to study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Inc.lead
Study Sites (10)
Unknown Facility
Inglewood, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Bloomfield, Connecticut, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
New Albany, Indiana, United States
Unknown Facility
Gretna, Louisiana, United States
Unknown Facility
Bangor, Maine, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 7, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 3, 2011
Record last verified: 2011-11