Efficacy and Safety of DNN.31.19.026 for Ocular Hypertension or Primary Open-Angle Glaucoma

NCT07617532 | Not Yet Recruiting Phase 3

• 1 other identifier: ACH-KRT-03(01/21)
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ocular Hypertension; Primary Open Angle Glaucoma

Outcome Measures

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.

  56 days

Study Arms (2)

Product DNN.31.19.026

EXPERIMENTAL

Drug: Product DNN.31.19.026

COSOPT®

ACTIVE COMPARATOR

Drug: COSOPT®

Interventions

Product DNN.31.19.026 DRUG

One drop in the affected eye twice daily

Product DNN.31.19.026

COSOPT® DRUG

One drop in the affected eye twice daily

COSOPT®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05