Dry EyePhase 4NCT06947850
DOMPE -MT Neurotrophic Keratitis
A Phase 4 study testing Cenegermin Ophthalmic Solution [Oxervate] in people with Dry Eye and Neurotrophic Keratitis, run by Toyos Clinic at 1 site in United States.
Trial summary
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Neurotrophic Keratitis
- What is being tested?
- Cenegermin Ophthalmic Solution [Oxervate]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2023to 25 Sep 2025
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Have a known hypersensitivity or contraindication to the investigational product or their components.
- Severe systemic allergy.
- Topical glaucoma medications or oral medications that are not being taken at a stable dose for the past 90 days.
- Topical dry eye medications within the last month except unpreserved artificial tears which will be allowed throughout the study as needed.
- Active viral, fungal or bacterial infection or active intraocular inflammation.
- Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial.
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- Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.
- Febrile illness within one week of screening visit.
- Treatment with another investigational drug or other investigational intervention withinone month of screening visit.
- Have serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance.
- Subjects that are currently pregnant or intend to become pregnant during the course of the study, are breastfeeding, or who are unwilling to use highly effective birth control measures such as hormonal contraceptives, and/or mechanical barrier methods during the course of the trial.
- Use of contact lenses during trial.
- Amniotic membranes within two weeks prior to screening.
- Punctal plugs will be allowed as long as they have remained stable for at least 90 days.
- No neurostimulation including varencicline, acupuncture or TrueTear or like devices within one month of screening.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment With Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
- Conditions
- Dry Eye, Neurotrophic Keratitis
- Being tested
- Cenegermin Ophthalmic Solution [Oxervate]
- Keywords
- dry eye, Neurotrophic Keratitis
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenegermin Ophthalmic Solution [Oxervate]Drug
Oxervate (cenegermin-bkbj) is commonly used to treat neurotrophic keratitis
| Study group | Role | What they receive |
|---|---|---|
| 8 week cenegermin treatment | Active comparator | All participants receive cenegermin topical ophthalmic drops 20mcg/ml six times daily for a treatment period of either 8 or 16 weeks followed by a follow up period total52 weeks total for each study arm. Receives: Drug: Cenegermin Ophthalmic Solution [Oxervate] |
| 16 week cenegermin | Active comparator | All participants receive cenegermin topical ophthalmic drops 20mcg/ml six times daily for a treatment period of either 8 or 16 weeks followed by a follow up period total52 weeks total for each study arm. Receives: Drug: Cenegermin Ophthalmic Solution [Oxervate] |
What is being measured
The primary outcome is the main question the study is designed to answer.
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start21 Jan 2023
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toyos Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947850
- Sponsor's protocol ID
- MMT-2021-02
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment With Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
- ClinicalTrials.gov ID
- NCT06947850
- Acronym / sponsor ID
- MMT-2021-02
- Conditions
- Dry Eye, Neurotrophic Keratitis
- Keywords
- dry eye, Neurotrophic Keratitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Toyos ClinicUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 27 Apr 2025 (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.
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 week cenegermin treatment | Active comparator | Drug: Cenegermin Ophthalmic Solution [Oxervate]All participants receive cenegermin topical ophthalmic drops 20mcg/ml six times daily for a treatment period of either 8 or 16 weeks followed by a follow up period total52 weeks total for each study arm. |
| 16 week cenegermin | Active comparator | Drug: Cenegermin Ophthalmic Solution [Oxervate]All participants receive cenegermin topical ophthalmic drops 20mcg/ml six times daily for a treatment period of either 8 or 16 weeks followed by a follow up period total52 weeks total for each study arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Have a known hypersensitivity or contraindication to the investigational product or their components.
- Severe systemic allergy.
- Topical glaucoma medications or oral medications that are not being taken at a stable dose for the past 90 days.
- Topical dry eye medications within the last month except unpreserved artificial tears which will be allowed throughout the study as needed.
- Active viral, fungal or bacterial infection or active intraocular inflammation.
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 |
|---|---|---|
| Cenegermin Ophthalmic Solution [Oxervate]Oxervate (cenegermin-bkbj) is commonly used to treat neurotrophic keratitis | Drug | 16 week cenegermin, 8 week cenegermin treatment |
Primary outcome
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
Time frame: 8 months
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 27 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 4 study testing Cenegermin Ophthalmic Solution [Oxervate] in people with Dry Eye and Neurotrophic Keratitis, run by Toyos Clinic 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 0 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis (time frame: 8 months). 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 27 Apr 2025.