Safety and Efficacy of a Drug Delivery System in Glaucoma
1 other identifier
interventional
47
1 country
5
Brief Summary
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 18, 2009
CompletedFirst Posted
Study publicly available on registry
November 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedResults Posted
Study results publicly available
January 27, 2012
CompletedMarch 6, 2015
February 1, 2015
4 months
November 18, 2009
September 26, 2011
February 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change in Intraocular Pressure at Day 1
Baseline to Day 1
Secondary Outcomes (4)
Mean Change in Intraocular Pressure at Day 2
Baseline to Day 2
Mean Change in Intraocular Pressure at Day 3
Baseline to Day 3
Mean Change in Intraocular Pressure at Day 4
Baseline to Day 4
Mean Change in Intraocular Pressure at Day 5
Day 4 to Day 5
Study Arms (3)
High Dose Drug Device/ bimatoprost 0.03%
EXPERIMENTALdrug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Low Dose Drug Device / bimatoprost 0.03%
EXPERIMENTALdrug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Placebo Device / bimatoprost 0.03%
OTHERplacebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Interventions
one drop in each eye on one day only
Eligibility Criteria
You may qualify if:
- Man or woman 21 years of age or greater
- Open angle glaucoma or ocular hypertension
- Corrected visual acuity in each eye of 20/200 or better
You may not qualify if:
- Previous glaucoma intraocular surgery or refractive surgery
- Planned contact lens use during the study
- Clinically significant ocular or systemic disease that might interfere with the study
- Use of chronic corticosteroids by any route
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Miami, Florida, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Rapid City, South Dakota, United States
Unknown Facility
Maryville, Tennessee, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brian Schwam MD
- Organization
- Vistakon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2009
First Posted
November 19, 2009
Study Start
October 1, 2009
Primary Completion
February 1, 2010
Last Updated
March 6, 2015
Results First Posted
January 27, 2012
Record last verified: 2015-02