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
• 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. 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

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma

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