Phase 2
Completed N=50
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Raised Intraocular Pressure
Source: ClinicalTrials.gov NCT01173471 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment — 0.8; -0.4; -8.1; -11.0 Percentage change — p=0.822
Summary
The purpose of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment |
0.8; -0.4; -8.1; -11.0 | 0.822 |
| SECONDARY Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment |
0; 0; 1; 4; 0; 0 | — |
| SECONDARY Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment |
0.1; -0.4; -1.9; -2.6 | 0.758 |
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle glaucoma (POAG), with IOP >20 mmHg and ≤36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit; OR
- Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP ≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication
- Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP
- Placebo treatment for duration of the study must not be considered detrimental to the patient
Exclusion Criteria
- Have uncontrolled intra-ocular hypertension (>36 mmHg)
- Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by >1 dB/yr average loss or vision threatening new defect)
- Have had severe eye trauma at any time
Data sourced from ClinicalTrials.gov (NCT01173471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.