Trial | NCT00683501  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dnb-001 ...

  • Study Participants

    54
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
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 Started
Oct 31
2007
Primary Completion
Aug 31
2008
Study Completion
Oct 31
2008
Last Update
Jun 03
2009
Estimate

Drug DNB-001

four dosages of DNB-001, one placebo dosage

1 Experimental

dosage X mg BID

2 Experimental

dosage Y mg BID

3 Experimental

dosage Z mg BID

4 Experimental

dosage 2Z mg BID

5 Placebo Comparator

Placebo BID

Criteria 

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.
No Results Posted