Phase 4
Completed N=201
Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution
Source: ClinicalTrials.gov NCT02325518 ↗Enrolled (actual)
201
Serious AEs
0.5%
Results posted
Dec 2016
Primary outcomePrimary: Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM — 17.0; 17.0; -3.3; -3.4 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM |
17.0; 17.0; -3.3; -3.4 | — |
| SECONDARY Least Squares Mean Change From Baseline in IOP at 9 AM |
17.4; 17.3; -3.3; -2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Understand the nature of the study and sign informed consent.
- Diagnosis of open angle glaucoma or ocular hypertension.
- Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.
- Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease.
- Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure.
- History of hypersensitivity to any of the excipients of the study medications.
- Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders.
- Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye.
- History of ocular trauma in either eye within 6 months prior to the screening examination.
- Ocular infection or ocular inflammation in either eye.
- History of or current clinically significant or progressive retinal disease in either eye.
- Intraocular surgery in either eye within 6 months prior to the screening examination.
- Ocular laser surgery in either eye within 3 months prior to the screening examination.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) in either eye.
- Severe visual field loss in either eye.
- Use of prohibited medication, as specified in the protocol.
- Pregnant, lactating, or intending to become pregnant during the study period.
- Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination.
- History of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02325518). 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.