GlaucomaPhase 4NCT07174401
Rocklatan Retinal Perfusion OCT Study
A Phase 4 study testing Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months. and Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. in people with Glaucoma, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The main purpose of this study is to learn more about how Rocklatan eye drops affects blood flow in the eye. The secondary purpose is to see if our study devices can detect changes in blood flow before and after instillation of Rocklatan. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months. and Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Oct 2027
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with both eyes with open angle glaucoma.
- Abnormal VF (glaucomatous pattern with PSD abnormal at p<0.05 or GHT outside normal limits) on most recent two clinic visits on chart review
- Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph
- Overall average NFL thickness > 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma
- NFLP-CD deficit (below 5 percentile of normal) in any of the 8 sectors on the initial baseline visit
- The difference in baseline NFLP-CD between the left and right eye should be less than 5% (% of area).
- IOP >= 17 mm Hg on the most recent two clinic visits (chart review) after monotherapy with latanoprost in both eyes.
Who cannot join
- Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit
- Age < 21 years at baseline
- Eye disease that could affect VF, NFL thickness, or NFLP (e.g., visually significant cataract, AMD, diabetic retinopathy, and optic neuropathy) at any study visit
- OCT and OCTA scans not meeting quality criteria at baseline
- Inability to cooperate with study procedures
- Inability to commit to the study visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Casey Eye Institute - Oregon Health & Science University
Portland, Oregon, 97239
Chinmay Deshpande, MS Optom, 503-494-9628, deshpanc@ohsu.edu
Denzil Romfh, OD, 503-494-4351, romfhd@ohsu.edu
About this study
Official title: Rocklatan Trial With Optical Coherence Tomography Study of Retinal Perfusion
The main purpose of this study is to learn more about how Rocklatan eye drops affects blood flow in the eye. The secondary purpose is to see if our study devices can detect changes in blood flow before and after instillation of Rocklatan.
- Conditions
- Glaucoma
- Being tested
- Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months., Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.
- Keywords
- Glaucoma, Rocklatan
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months.Drug
The eye not selected as the study eye will be used for comparison so both eyes will be imaged with the study devices to assess blood flow changes.
Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.Device
One OCT device is FDA-cleared while the other is still experimental. Both devices assess blood flow in different ways.
| Study group | Role | What they receive |
|---|---|---|
| Eye with Diagnosed Glaucoma | Experimental | Not described Receives: Drug: Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months.; Device: Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. |
| Control Eye | No intervention | This is also an eye with glaucoma, but the control eye will use clinically prescribed medication instead of the study drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Fiber Layer Plexus Capillary Density (NFLP CD)
The primary outcome measure will be change in the overall peripapillary NFLP CD measured at 6 months and 11-12 month endpoint visits compared to baseline values.
Measured: From enrollment to end of treatment at 11-12 months
Secondary outcomes (1)
Total Retinal Blood Flow (TRBF)
Secondary outcome measures will include change in the TRBF measured at 6 months or 11-12 month endpoint visits compared to baseline.
Measured: From enrollment to end of treatment at 11-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- David Huang, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174401
- Sponsor's protocol ID
- OHSU IRB0029104
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rocklatan Trial With Optical Coherence Tomography Study of Retinal Perfusion
- ClinicalTrials.gov ID
- NCT07174401
- Acronym / sponsor ID
- OHSU IRB0029104
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Rocklatan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 16 Sep 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.
The main purpose of this study is to learn more about how Rocklatan eye drops affects blood flow in the eye. The secondary purpose is to see if our study devices can detect changes in blood flow before and after instillation of Rocklatan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye with Diagnosed Glaucoma | Experimental | Drug: Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months., Device: Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. |
| Control Eye | No intervention | –This is also an eye with glaucoma, but the control eye will use clinically prescribed medication instead of the study drug. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with both eyes with open angle glaucoma.
- Abnormal VF (glaucomatous pattern with PSD abnormal at p<0.05 or GHT outside normal limits) on most recent two clinic visits on chart review
- Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph
- Overall average NFL thickness > 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma
- NFLP-CD deficit (below 5 percentile of normal) in any of the 8 sectors on the initial baseline visit
Key exclusion criteria (6 listed)
- Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit
- Age < 21 years at baseline
- Eye disease that could affect VF, NFL thickness, or NFLP (e.g., visually significant cataract, AMD, diabetic retinopathy, and optic neuropathy) at any study visit
- OCT and OCTA scans not meeting quality criteria at baseline
- Inability to cooperate with study procedures
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 |
|---|---|---|
| Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months.The eye not selected as the study eye will be used for comparison so both eyes will be imaged with the study devices to assess blood flow changes. | Drug | Eye with Diagnosed Glaucoma |
| Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.One OCT device is FDA-cleared while the other is still experimental. Both devices assess blood flow in different ways. | Device | Eye with Diagnosed Glaucoma |
Primary outcome
Nerve Fiber Layer Plexus Capillary Density (NFLP CD)
Time frame: From enrollment to end of treatment at 11-12 months
The primary outcome measure will be change in the overall peripapillary NFLP CD measured at 6 months and 11-12 month endpoint visits compared to baseline values.
1 secondary outcome
Total Retinal Blood Flow (TRBF)
Time frame: From enrollment to end of treatment at 11-12 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 24 Dec 2025.
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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.
David Huang, MD, PhD principal investigator
Oregon Health and Science University
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 Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months. and Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. in people with Glaucoma, run by Oregon Health and Science University 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 7 inclusion and 6 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 24 Dec 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?
Contact Chinmay Deshpande, MS Optom (503-494-9628, deshpanc@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve Fiber Layer Plexus Capillary Density (NFLP CD) (time frame: From enrollment to end of treatment at 11-12 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 24 Dec 2025.