Efficacy and Safety of DNN.31.19.026 for Ocular Hypertension or Primary Open-Angle Glaucoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAche Laboratorios Farmaceuticos S.A.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Product DNN.31.19.026
DrugOne drop in the affected eye twice daily
COSOPT®
DrugOne drop in the affected eye twice daily
Treatment groups
336 Participants
are divided into 2 treatment groupsGroup A: Product DNN.31.19.026Experimental treatment 1 intervention
Group B: COSOPT®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean change from baseline in diurnal intraocular pressure (IOP)
Absolute change from baseline in mean diurnal intraocular pressure (IOP) at Day 56 after treatment initiation.
Time frame
56 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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