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Completed

NCT Number: NCT00683501

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

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

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Key information

Conditions

Ocular Hypertension Elevated IOP Eye Diseases Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Omnicare Clinical Research Center

Chippenham, Wiltshire, SN14 6NQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DNB-001

Drug

four dosages of DNB-001, one placebo dosage

Primary outcomes

  1. 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

    Time frame: 28 days of therapy

Secondary outcomes

  1. Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7

    Time frame: 7, 14, 21 days of therapy

Sponsors and collaborators

Lead sponsor

Danube Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: DNB-001

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 23, 2008
Registry last updated
Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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