Open Angle GlaucomaPhase 2/3WhistlerNCT05938699
Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution
A Phase 2/3 study testing NCX 470 in people with Open Angle Glaucoma, run by Nicox Ophthalmics, Inc. at 1 site in United States.
Trial summary
This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- NCX 470
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 17 Mar 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Either gender
- Subjects without glaucoma
- Qualifying IOP at Screening Visit
Who cannot join
- Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
- Clinically significant ocular disease in either eye
- Uncontrolled systemic disease
- Serious hypersensitivity to topical anesthetic eye drops
- Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler)
This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.
- Conditions
- Open Angle Glaucoma
- Being tested
- NCX 470, Placebo
- Keywords
- glaucoma, NCX 470, nitric oxide, prostaglandin analogue
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCX 470Drug
Also called nitric oxide (NO)-donating bimatoprost prostaglandin analog
NCX 470 0.1% vs Placebo
PlaceboDrug
Also called Artificial tears
NCX 0.1% vs Placebo
| Study group | Role | What they receive |
|---|---|---|
| NCX 470 0.1% | Active comparator | NCX 470 0.1% - one drop in the randomized eye once a day for 8 days Receives: Drug: NCX 470 |
| Placebo | Placebo comparator | Artificial tears - one drop in the randomized eye once a day for 8 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AHD
The primary efficacy endpoint is change from baseline in aqueous humor dynamics AHD). AHD is calculated by using well establish techniques which include capturing the following:
Aqueous humor flow rates from fluorescein clearance; Outflow facility using constant weigh tonography; Episcleral venous pressure using a venomanometer.
The change in ADH will be calculate in normals following 8 (±1) days of dosing of NCX 470 0.1% compared to placebo.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start12 Dec 2023
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicox Ophthalmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938699
- Sponsor's protocol ID
- NCX 470-05
- Acronym
- Whistler
- Status last verified
- Sep 2025
- First submitted
- 15 Jun 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler)
- ClinicalTrials.gov ID
- NCT05938699
- Acronym / sponsor ID
- Whistler / NCX 470-05
- Conditions
- Open Angle Glaucoma
- Keywords
- glaucoma, NCX 470, nitric oxide, prostaglandin analogue
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nicox Ophthalmics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 10 Jul 2023 (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 is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCX 470 0.1% | Active comparator | Drug: NCX 470NCX 470 0.1% - one drop in the randomized eye once a day for 8 days |
| Placebo | Placebo comparator | Drug: PlaceboArtificial tears - one drop in the randomized eye once a day for 8 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- Either gender
- Subjects without glaucoma
- Qualifying IOP at Screening Visit
Key exclusion criteria (5 listed)
- Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
- Clinically significant ocular disease in either eye
- Uncontrolled systemic disease
- Serious hypersensitivity to topical anesthetic eye drops
- Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
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 470Also: nitric oxide (NO)-donating bimatoprost prostaglandin analogNCX 470 0.1% vs Placebo | Drug | NCX 470 0.1% |
| PlaceboAlso: Artificial tearsNCX 0.1% vs Placebo | Drug | Placebo |
Primary outcome
Change in AHD
Time frame: 8 days
The primary efficacy endpoint is change from baseline in aqueous humor dynamics AHD). AHD is calculated by using well establish techniques which include capturing the following: Aqueous humor flow rates from fluorescein clearance; Outflow facility using constant weigh tonography; Episcleral venous pressure using a venomanometer. The change in ADH will be calculate in normals following 8 (±1) days of dosing of NCX 470 0.1% compared to placebo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NCX 470 in people with Open Angle Glaucoma, 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 8 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in AHD (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.