Efficacy and Safety of DNN.31.19.026 for Ocular Hypertension or Primary Open-Angle Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Product DNN.31.19.026, COSOPT®.
- Who it may be relevant to
- Registry conditions: Ocular Hypertension, Primary Open Angle Glaucoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Clinical Trial to Evaluate the Safety and Efficacy of DNN.31.19.026 for the Treatment of Ocular Hypertension or Primary Open-Angle Glaucoma
Overview
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
- Drug Product DNN.31.19.026
One drop in the affected eye twice daily - Drug COSOPT®
One drop in the affected eye twice daily
Primary outcome measures
- Mean change from baseline in diurnal intraocular pressure (IOP) [Time frame: 56 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07617532 · ACH-KRT-03(01/21)