Status:
COMPLETED
Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure
Lead Sponsor:
Danube Pharmaceuticals, Inc.
Conditions:
Ocular Hypertension
Elevated IOP
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Untrea...
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00683501
Start Date
October 1 2007
End Date
October 1 2008
Last Update
June 3 2009
Active Locations (1)
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1
Omnicare Clinical Research Center
Chippenham, Wiltshire, United Kingdom, SN14 6NQ