Open Angle GlaucomaPhase 3Mont BlancNCT04445519
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing NCX 470 0.065% (initial phase of trial), Latanoprost 0.005% (initial phase of trial) and NCX 470 0.1% (initial phase of trial) in people with Open Angle Glaucoma and Ocular Hypertension, run by Nicox Ophthalmics, Inc. at 1 site in United States.
Trial summary
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- NCX 470 0.065% (initial phase of trial), Latanoprost 0.005% (initial phase of trial) and NCX 470 0.1% (initial phase of trial)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 691 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 16 Sep 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
- Qualifying best-corrected visual acuity in each eye
- Ability to provide informed consent and follow study instructions
Who cannot join
- Narrow anterior chamber angles or disqualifying corneal thickness in either eye
- Clinically significant ocular disease in either eye
- Previous complicated surgery or certain types of glaucoma surgery in either eye
- Incisional ocular surgery or severe trauma in either eye within the past 6 months
- Uncontrolled systemic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation
Newport Beach, California, 92663
About this study
Official title: Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- NCX 470 0.065% (initial phase of trial), Latanoprost 0.005% (initial phase of trial), NCX 470 0.1% (initial phase of trial), NCX 470 0.1% (remainder of trial), Latanoprost 0.005% (remainder of trial)
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCX 470 0.065% (initial phase of trial)Drug
NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
Latanoprost 0.005% (initial phase of trial)Drug
Also called Latanoprost
Latanoprost Ophthalmic Solution, 0.005%
NCX 470 0.1% (initial phase of trial)Drug
NCX 470 Ophthalmic Solution, 0.1%
NCX 470 0.1% (remainder of trial)Drug
NCX 470 Ophthalmic Solution, 0.1%
Latanoprost 0.005% (remainder of trial)Drug
Latanoprost Ophthalmic Solution, 0.005%
| Study group | Role | What they receive |
|---|---|---|
| NCX 470 0.065% | Experimental | NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial) Receives: Drug: NCX 470 0.065% (initial phase of trial) |
| NCX 470 0.1% | Experimental | NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial) Receives: Drug: NCX 470 0.1% (initial phase of trial) |
| Latanoprost 0.005% | Active comparator | Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial) Receives: Drug: Latanoprost 0.005% (initial phase of trial) |
| NCX 470 0.1% (remainder of trial) | Experimental | NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial) Receives: Drug: NCX 470 0.1% (remainder of trial) |
| Latanoprost 0.005% (remainder of trial) | Active comparator | Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial) Receives: Drug: Latanoprost 0.005% (remainder of trial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group.
The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.
Measured: Baseline, Week 2, Week 6, and Month 3
Secondary outcomes (3)
Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye
Subjects in the NCX 470 0.065% treatment group were discontinued at Week 2 based upon the results of the planned, interim analysis.
Subjects in the NCX 470 0.1% and Latanoprost 0.005% treatment groups continued for 3 months.
Participants used medication in both eyes for 3 months with 1 eye designated as study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline).
Measured: Baseline, Week 2, Week 6, and Month 3
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Safety and tolerability based on number subjects with treatment emergent ocular adverse events.
Measured: 3 months
Rate of Discontinuation
Number of subjects discontinued from the study.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jun 2020
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicox Ophthalmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicox Ophthalmics, Inc., Study director, Nicox Ophthalmics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445519
- Sponsor's protocol ID
- NCX-470-02
- Acronym
- Mont Blanc
- Status last verified
- Mar 2025
- First submitted
- 19 Jun 2020
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansberger SL, Fechtner R, Lopez K, Hubatsch D. A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study. Contemp Clin Trials. 2024 Dec;147:107730. doi: 10.1016/j.cct.2024.107730. Epub 2024 Oct 28.
PubMed 39477206
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
- ClinicalTrials.gov ID
- NCT04445519
- Acronym / sponsor ID
- Mont Blanc / NCX-470-02
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Nicox Ophthalmics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NCX 470 0.065% | Experimental | Drug: NCX 470 0.065% (initial phase of trial)NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial) |
| NCX 470 0.1% | Experimental | Drug: NCX 470 0.1% (initial phase of trial)NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial) |
| Latanoprost 0.005% | Active comparator | Drug: Latanoprost 0.005% (initial phase of trial)Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial) |
| NCX 470 0.1% (remainder of trial) | Experimental | Drug: NCX 470 0.1% (remainder of trial)NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial) |
| Latanoprost 0.005% (remainder of trial) | Active comparator | Drug: Latanoprost 0.005% (remainder of trial)Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial) |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
- Qualifying best-corrected visual acuity in each eye
- Ability to provide informed consent and follow study instructions
Key exclusion criteria (5 listed)
- Narrow anterior chamber angles or disqualifying corneal thickness in either eye
- Clinically significant ocular disease in either eye
- Previous complicated surgery or certain types of glaucoma surgery in either eye
- Incisional ocular surgery or severe trauma in either eye within the past 6 months
- Uncontrolled systemic disease
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 |
|---|---|---|
| NCX 470 0.065% (initial phase of trial)NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial) | Drug | NCX 470 0.065% |
| Latanoprost 0.005% (initial phase of trial)Also: LatanoprostLatanoprost Ophthalmic Solution, 0.005% | Drug | Latanoprost 0.005% |
| NCX 470 0.1% (initial phase of trial)NCX 470 Ophthalmic Solution, 0.1% | Drug | NCX 470 0.1% |
| NCX 470 0.1% (remainder of trial)NCX 470 Ophthalmic Solution, 0.1% | Drug | NCX 470 0.1% (remainder of trial) |
| Latanoprost 0.005% (remainder of trial)Latanoprost Ophthalmic Solution, 0.005% | Drug | Latanoprost 0.005% (remainder of trial) |
Primary outcome
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
Time frame: Baseline, Week 2, Week 6, and Month 3
The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.
3 secondary outcomes
Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye
Time frame: Baseline, Week 2, Week 6, and Month 3
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Time frame: 3 months
Rate of Discontinuation
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39477206Mansberger SL, Fechtner R, Lopez K, Hubatsch D. A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study. Contemp Clin Trials. 2024 Dec;147:107730. doi: 10.1016/j.cct.2024.107730. Epub 2024 Oct 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nicox Ophthalmics, Inc. study director
Nicox Ophthalmics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NCX 470 0.065% (initial phase of trial), Latanoprost 0.005% (initial phase of trial) and NCX 470 0.1% (initial phase of trial) in people with Open Angle Glaucoma and Ocular Hypertension, run by Nicox Ophthalmics, Inc. at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3 (time frame: Baseline, Week 2, Week 6, and Month 3). 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 NCT04445519, which also lists 1 linked publication.
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 24 Jun 2025.