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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
four dosages of DNB-001, one placebo dosage
Omnicare Clinical Research Center
Chippenham, Wiltshire, United Kingdom
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
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
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