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

Phase 1

Completed

• Conditions: Ocular Hypertension; Elevated IOP; Glaucoma
• Interventions: Drug: DNB-001

• Registration Number: NCT00683501
• Lead Sponsor: Danube Pharmaceuticals, Inc.

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2008-08
• Study Completion: 2008-10
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	DNB-001	dosage 2Z mg BID
1	DNB-001	dosage X mg BID
2	DNB-001	dosage Y mg BID
3	DNB-001	dosage Z mg BID
5	DNB-001	Placebo BID

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Omnicare Clinical Research Center; 🇬🇧 Chippenham, Wiltshire, United Kingdom