Ocular HypertensionPhase 3RENOIRNCT07617532

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

A Phase 3 study testing Product DNN.31.19.026 and COSOPT® in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by Ache Laboratorios Farmaceuticos S.A..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Hypertension, Primary Open Angle Glaucoma
What is being tested?: Product DNN.31.19.026 and COSOPT®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 336 participants
Where: No sites listed yet
Study dates: Jun 2026to Mar 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

About this study

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

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
Being tested: Product DNN.31.19.026, COSOPT®
Medical subject headings: Ocular Hypertension, Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Product DNN.31.19.026Drug
One drop in the affected eye twice daily
COSOPT®Drug
One drop in the affected eye twice daily

Study groups in NCT07617532
Study group	Role	What they receive
Product DNN.31.19.026	Experimental	Not described Receives: Drug: Product DNN.31.19.026
COSOPT®	Active comparator	Not described Receives: Drug: COSOPT®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2026Mar 2028

First posted1 Jun 2026
Study startJun 2026 (estimated)
Primary completionMar 2028 (estimated)
Study completionMar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ocular HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 336 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07617532
Sponsor's protocol ID: ACH-KRT-03(01/21)
Acronym: RENOIR
Status last verified: May 2026
First submitted: 25 May 2026
Last updated: 1 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07617532
Acronym / sponsor ID: RENOIR / ACH-KRT-03(01/21)
Conditions: Ocular Hypertension, Primary Open Angle Glaucoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 336 participants (estimated)
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
Study start: Jun 2026 (estimated)
Primary completion: Mar 2028 (estimated)
Study completion: Mar 2028 (estimated)
First posted: 1 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Product DNN.31.19.026	Experimental	Drug: Product DNN.31.19.026
COSOPT®	Active comparator	Drug: COSOPT®

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Product DNN.31.19.026One drop in the affected eye twice daily	Drug	Product DNN.31.19.026
COSOPT®One drop in the affected eye twice daily	Drug	COSOPT®

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Product DNN.31.19.026 and COSOPT® in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by Ache Laboratorios Farmaceuticos S.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in diurnal intraocular pressure (IOP) (time frame: 56 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07617532.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.