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Safety and Efficacy of a Drug Delivery System in Glaucoma

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ClinicalTrials.gov Identifier: NCT01016691
Recruitment Status : Completed
First Posted : November 19, 2009
Results First Posted : January 27, 2012
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mean Change in Intraocular Pressure at Day 1 [ Time Frame: Baseline to Day 1 ]

Secondary Outcome Measures :
  1. Mean Change in Intraocular Pressure at Day 2 [ Time Frame: Baseline to Day 2 ]
  2. Mean Change in Intraocular Pressure at Day 3 [ Time Frame: Baseline to Day 3 ]
  3. Mean Change in Intraocular Pressure at Day 4 [ Time Frame: Baseline to Day 4 ]
  4. Mean Change in Intraocular Pressure at Day 5 [ Time Frame: Day 4 to Day 5 ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01016691     History of Changes
Other Study ID Numbers: CR-1649
First Posted: November 19, 2009    Key Record Dates
Results First Posted: January 27, 2012
Last Update Posted: March 6, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Bimatoprost
Pharmaceutical Solutions
Antihypertensive Agents