Glaucoma, Open-AngleEarly Phase 1NCT04234932
Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
A Early Phase 1 study testing Netarsudil Ophthalmic in people with Glaucoma, Open-Angle, run by University of the Incarnate Word at 1 site in United States.
Trial summary
Investigate changes in optical coherence tomography angiography of the optic nerve and macula following topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Netarsudil Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to Jan 2021
- Phase
- Early Phase 1
- 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
- Normal ocular health
Who cannot join
- Females who are or may be pregnant or who are nursing
- Uncontrolled hypertension
- Allergy to netarsudil or latanoprost
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of the Incarnate Word
San Antonio, Texas, 78209
Ana C Hagendorf, PhD, 210-805-3036, wandless@uiwtx.edu
About this study
Investigate changes in optical coherence tomography angiography of the optic nerve and macula following topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Netarsudil Ophthalmic
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil OphthalmicDrug
Also called Latanoprost Ophthalmic
Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil alone | Experimental | Topical application of netarsudil 0.02% Receives: Drug: Netarsudil Ophthalmic |
| Netarsudil plus latanoprost | Active comparator | Topical application of netarsudil 0.02% with latanoprost 0.005% Receives: Drug: Netarsudil Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripapillary capillary perfusion density
Mean change in peripapillary capillary perfusion as assessed using optical coherence tomography angiography
Measured: 90 minutes
Secondary outcomes (1)
Macular capillary perfusion density
Mean change in macular capillary perfusion as assessed using optical coherence tomography angiography
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start6 Jan 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Trevino, OD, FAAO, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234932
- Sponsor's protocol ID
- 19-12-005
- Status last verified
- Apr 2020
- First submitted
- 15 Jan 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
- ClinicalTrials.gov ID
- NCT04234932
- Acronym / sponsor ID
- 19-12-005
- Conditions
- Glaucoma, Open-Angle
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 21 Jan 2020 (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.
Investigate changes in optical coherence tomography angiography of the optic nerve and macula following topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netarsudil alone | Experimental | Drug: Netarsudil OphthalmicTopical application of netarsudil 0.02% |
| Netarsudil plus latanoprost | Active comparator | Drug: Netarsudil OphthalmicTopical application of netarsudil 0.02% with latanoprost 0.005% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal ocular health
Key exclusion criteria (3 listed)
- Females who are or may be pregnant or who are nursing
- Uncontrolled hypertension
- Allergy to netarsudil or latanoprost
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 |
|---|---|---|
| Netarsudil OphthalmicAlso: Latanoprost OphthalmicTopical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan) | Drug | Netarsudil alone, Netarsudil plus latanoprost |
Primary outcome
Peripapillary capillary perfusion density
Time frame: 90 minutes
Mean change in peripapillary capillary perfusion as assessed using optical coherence tomography angiography
1 secondary outcome
Macular capillary perfusion density
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Netarsudil Ophthalmic in people with Glaucoma, Open-Angle, run by University of the Incarnate Word 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Jo Bilicek (210-805-3565, bilicek@uiwtx.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripapillary capillary perfusion density (time frame: 90 minutes). 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 14 Apr 2020.