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

May 25, 2026 updated by: Ache Laboratorios Farmaceuticos S.A.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

336

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Product DNN.31.19.026
Drug: Product DNN.31.19.026
One drop in the affected eye twice daily
Active Comparator: COSOPT®
Drug: COSOPT®
One drop in the affected eye twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in diurnal intraocular pressure (IOP)
Time Frame: 56 days
Absolute change from baseline in mean diurnal intraocular pressure (IOP) at Day 56 after treatment initiation.
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

May 25, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACH-KRT-03(01/21)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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