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

Study Overview
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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

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.

Official Title
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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

Conditions
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Ocular Hypertension, Elevated IOP, Glaucoma

Intervention / Treatment
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* Drug: DNB-001


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>dosage X mg BID | Drug: DNB-001<br>* four dosages of DNB-001, one placebo dosage<br>|
| Experimental: 2<br>dosage Y mg BID | Drug: DNB-001<br>* four dosages of DNB-001, one placebo dosage<br>|
| Experimental: 3<br>dosage Z mg BID | Drug: DNB-001<br>* four dosages of DNB-001, one placebo dosage<br>|
| Experimental: 4<br>dosage 2Z mg BID | Drug: DNB-001<br>* four dosages of DNB-001, one placebo dosage<br>|
| Placebo Comparator: 5<br>Placebo BID | Drug: DNB-001<br>* four dosages of DNB-001, one placebo dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28 days of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7 |  | 7, 14, 21 days of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular hypertension, elevated IOP, glaucoma, neuroprotection