search
Back to results

Safety and Efficacy of a Drug Delivery System in Glaucoma

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Dose Drug Device
Low Dose Drug Device
Placebo Device
bimatoprost 0.03%
Sponsored by
Vistakon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

High Dose Drug Device/ bimatoprost 0.03%

Low Dose Drug Device / bimatoprost 0.03%

Placebo Device / bimatoprost 0.03%

Arm Description

drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).

drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).

placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).

Outcomes

Primary Outcome Measures

Mean Change in Intraocular Pressure at Day 1

Secondary Outcome Measures

Mean Change in Intraocular Pressure at Day 2
Mean Change in Intraocular Pressure at Day 3
Mean Change in Intraocular Pressure at Day 4
Mean Change in Intraocular Pressure at Day 5

Full Information

First Posted
November 18, 2009
Last Updated
February 18, 2015
Sponsor
Vistakon Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01016691
Brief Title
Safety and Efficacy of a Drug Delivery System in Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vistakon Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
High Dose Drug Device/ bimatoprost 0.03%
Arm Type
Experimental
Arm Description
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Arm Title
Low Dose Drug Device / bimatoprost 0.03%
Arm Type
Experimental
Arm Description
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Arm Title
Placebo Device / bimatoprost 0.03%
Arm Type
Other
Arm Description
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Intervention Type
Drug
Intervention Name(s)
High Dose Drug Device
Intervention Description
device inserted for 4 days
Intervention Type
Drug
Intervention Name(s)
Low Dose Drug Device
Intervention Description
device inserted for 4 days
Intervention Type
Drug
Intervention Name(s)
Placebo Device
Intervention Description
device inserted for 4 days
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03%
Intervention Description
one drop in each eye on one day only
Primary Outcome Measure Information:
Title
Mean Change in Intraocular Pressure at Day 1
Time Frame
Baseline to Day 1
Secondary Outcome Measure Information:
Title
Mean Change in Intraocular Pressure at Day 2
Time Frame
Baseline to Day 2
Title
Mean Change in Intraocular Pressure at Day 3
Time Frame
Baseline to Day 3
Title
Mean Change in Intraocular Pressure at Day 4
Time Frame
Baseline to Day 4
Title
Mean Change in Intraocular Pressure at Day 5
Time Frame
Day 4 to Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
City
Miami
State/Province
Florida
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Rapid City
State/Province
South Dakota
Country
United States
City
Maryville
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of a Drug Delivery System in Glaucoma

We'll reach out to this number within 24 hrs