Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Brief summary
This study aims to evaluate the safety and efficacy of DNN.31.19.026 compared with Cosopt® for the treatment of ocular hypertension or primary open-angle glaucoma.
Interventions
DRUGProduct DNN.31.19.026
One drop in the affected eye twice daily
DRUGCOSOPT®
One drop in the affected eye twice daily
Sponsors
Ache Laboratorios Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants of either sex, aged ≥18 years; * Participants diagnosed with ocular hypertension or primary open-angle glaucoma according to the Clinical Protocol and Therapeutic Guidelines for Glaucoma; * Participants requiring ocular hypotensive treatment in one or both eyes, for whom the use of combination topical ocular hypotensive medications is appropriate for intraocular pressure (IOP) reduction.
Exclusion criteria
* Participants diagnosed with primary open-angle glaucoma with no prior treatment history for the disease; * Participants with a cup-to-disc ratio \>0.8 (horizontal or vertical); * Participants with any other clinically significant ocular disease that, in the investigator's opinion, may interfere with the evaluation of study efficacy and safety variables; * Participants with ocular infection or inflammation within 3 months prior to the screening/run-in visit; * Participants with a history of trabeculoplasty (within the last 6 months) or surgical procedures for IOP reduction; * Participants with a history of ocular surgery within 6 months prior to the screening/run-in visit; * Participants with any corneal abnormality that may affect IOP measurement; * Participants with respiratory or pulmonary disorders, such as asthma or chronic obstructive pulmonary disease (COPD); * Participants with the following cardiac conditions: sinus bradycardia, sinoatrial block, second- or third-degree atrioventricular block, overt heart failure, or cardiogenic shock; * Participants with uncontrolled systemic diseases, such as diabetes, hypertension, chronic hepatic or renal disorders, or any other medical condition that, in the investigator's opinion, may interfere with the investigational product or comparator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in diurnal intraocular pressure (IOP) | 56 days | Absolute change from baseline in mean diurnal intraocular pressure (IOP) at Day 56 after treatment initiation. |
Outcome results
None listed