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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ocular Hypertension Elevated IOP Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

four dosages of DNB-001, one placebo dosage

Interventions

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DNB-001

four dosages of DNB-001, one placebo dosage

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No