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Safety and Efficacy of a Drug Delivery System in Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01016691
First received: November 18, 2009
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: High Dose Drug Device
Drug: Low Dose Drug Device
Drug: Placebo Device
Drug: bimatoprost 0.03%
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Bimatoprost
U.S. FDA Resources

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:
  • Mean Change in Intraocular Pressure at Day 1 [ Time Frame: Baseline to Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean Change in Intraocular Pressure at Day 2 [ Time Frame: Baseline to Day 2 ] [ Designated as safety issue: Yes ]
  • Mean Change in Intraocular Pressure at Day 3 [ Time Frame: Baseline to Day 3 ] [ Designated as safety issue: Yes ]
  • Mean Change in Intraocular Pressure at Day 4 [ Time Frame: Baseline to Day 4 ] [ Designated as safety issue: Yes ]
  • Mean Change in Intraocular Pressure at Day 5 [ Time Frame: Day 4 to Day 5 ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: October 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose Drug Device/ bimatoprost 0.03%
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
 Drug: High Dose Drug Device
device inserted for 4 days
Drug: bimatoprost 0.03%
one drop in each eye on one day only
Experimental: Low Dose Drug Device / bimatoprost 0.03%
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
 Drug: Low Dose Drug Device
device inserted for 4 days
Drug: bimatoprost 0.03%
one drop in each eye on one day only
Placebo Device / bimatoprost 0.03%
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
 Drug: Placebo Device
device inserted for 4 days
Drug: bimatoprost 0.03%
one drop in each eye on one day only

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016691

Locations
United States, Florida
Miami, Florida, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Mount Pleasant, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Maryville, Tennessee, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
  More Information

No publications provided

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01016691     History of Changes
Other Study ID Numbers: CR-1649
Study First Received: November 18, 2009
Results First Received: September 26, 2011
Last Updated: December 20, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013