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NCT01016691 Clinical Trial

Safety and Efficacy of a Drug Delivery System in Glaucoma

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01016691
Other study ID # CR-1649
Secondary ID
Status Completed
Phase Phase 2
First received November 18, 2009
Last updated February 18, 2015
Start date October 2009

Study information
Verified date February 2015
Source Vistakon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• High Dose Drug Device
device inserted for 4 days
• Low Dose Drug Device
device inserted for 4 days
• Placebo Device
device inserted for 4 days
• bimatoprost 0.03%
one drop in each eye on one day only

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change in Intraocular Pressure at Day 1 Baseline to Day 1 Yes
Secondary Mean Change in Intraocular Pressure at Day 2 Baseline to Day 2 Yes
Secondary Mean Change in Intraocular Pressure at Day 3 Baseline to Day 3 Yes
Secondary Mean Change in Intraocular Pressure at Day 4 Baseline to Day 4 Yes
Secondary Mean Change in Intraocular Pressure at Day 5 Day 4 to Day 5 Yes
See also
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