Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure

Glaucoma Clinical Trial

— DNB-001  

Official title:

A Phase II Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients With Elevated Intraocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683501
• Other study ID #: DNB-001-CT001
• Secondary ID: EudoraCT 2006-00
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 21, 2008
• Last updated: June 2, 2009
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: June 2009
• Source: Danube Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients with intraocular Hypertension

Description:

To evaluate the efficacy of four dosages of mg DNB-001 administered twice daily (bid) per os (p.o.) as an anti-ocular hypertensive agent, compared with placebo administered bid po, for 28 days, in patients with ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (IOP), with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/50 or better in each eye and lOP of 21 to 29 mm Hg at baseline.

Exclusion Criteria:

• Use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma

• Evidence of potential angle closure by gonioscopy

• Abnormal optic disc or visual field consistent with glaucoma

• Use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elevated IOP
• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• DNB-001
four dosages of DNB-001, one placebo dosage

Locations

Country	Name	City	State
United Kingdom	Omnicare Clinical Research Center	Chippenham	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Danube Pharmaceuticals, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction of IOP as calculated on the basis of the arithmetic mean of up to six measurements of IOP, comparing baseline to visit 6		28 days of therapy	No
Secondary	Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7		7, 14, 21 days of therapy	No