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CompletedNCT00683501DNB-001Updated Jun 3, 2009

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

A Phase 1/2 interventional study of DNB-001 in Ocular Hypertension, Elevated IOP and Glaucoma, sponsored by Danube Pharmaceuticals, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-03.

Sponsored by Danube Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Ocular Hypertension
  • Elevated IOP
  • Glaucoma

Keywords

  • ocular hypertension
  • elevated IOP
  • glaucoma
  • neuroprotection
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 54 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

This is the only study on the registry with Danube Pharmaceuticals, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    1

    dosage X mg BID

    Drug: DNB-001

  • Experimental
    2

    dosage Y mg BID

    Drug: DNB-001

  • Experimental
    3

    dosage Z mg BID

    Drug: DNB-001

  • Experimental
    4

    dosage 2Z mg BID

    Drug: DNB-001

  • Placebo comparator
    5

    Placebo BID

    Drug: DNB-001

Interventions

  • DrugDNB-001

    four dosages of DNB-001, one placebo dosage

06

What researchers measure

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

07

Study locations

1 site
  • Omnicare Clinical Research Center
    Chippenham, Wiltshire SN14 6NQ, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00683501
Lead sponsor
Danube Pharmaceuticals, Inc.
First posted
May 23, 2008
Start date
Oct 2007
Primary completion
Aug 2008
Completion
Oct 2008
Last update
Jun 3, 2009

Study contacts

Barrett Katz, MD
study chair · CEO, CMO, Danube Pharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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