Safety and Efficacy of a Glaucoma Drug Delivery System

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824720
• Other study ID #: CR-1630
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2009
• Last updated: February 18, 2015
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2015
• Source: Vistakon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Man or woman 21 years of age or greater

• must have 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

Intervention

Drug:
• High Dose Device
inserted for 14 days
• Low Dose Device
inserted for 14 days

Device:
• Placebo Device
inserted for 14 days

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	Visual Acuity - Right Eye	This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.	at 14 days	Yes
Primary	Visual Acuity - Left Eye	This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.	at 14 days	Yes
Secondary	Intraocular Pressure (IOP)		from baseline to 14 days	Yes