Safety and Efficacy of a Glaucoma Drug Delivery System
1 other identifier
interventional
55
1 country
4
Brief Summary
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma 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
Started Dec 2008
Shorter than P25 for phase_2
4 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
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 9, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
May 14, 2010
CompletedMarch 6, 2015
February 1, 2015
4 months
January 9, 2009
April 15, 2010
February 18, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Visual Acuity - Right Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
at 14 days
Visual Acuity - Left Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
at 14 days
Secondary Outcomes (1)
Intraocular Pressure (IOP)
from baseline to 14 days
Study Arms (3)
High Dose Device
EXPERIMENTALdevice worn continuously for 14 days
Low Dose Device
EXPERIMENTALdevice worn continuously for 14 days
Placebo Device
PLACEBO COMPARATORdevice worn continuously for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Man or woman 21 years of age or greater
- must have 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 (4)
Unknown Facility
Artesia, California, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Baltimore, Maryland, USA, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brian Schwam MD/Director Clinical Affairs & Ocular Sciences
- 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
January 9, 2009
First Posted
January 19, 2009
Study Start
December 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
March 6, 2015
Results First Posted
May 14, 2010
Record last verified: 2015-02