Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2026-01-31
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Eye with Diagnosed Glaucoma
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.
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.
Control Eye
This is also an eye with glaucoma, but the control eye will use clinically prescribed medication instead of the study drug.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph
4. Overall average NFL thickness \> 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma
5. NFLP-CD deficit (below 5 percentile of normal) in any of the 8 sectors on the initial baseline visit
6. The difference in baseline NFLP-CD between the left and right eye should be less than 5% (% of area).
7. IOP \>= 17 mm Hg on the most recent two clinic visits (chart review) after monotherapy with latanoprost in both eyes.
Exclusion Criteria
2. Age \< 21 years at baseline
3. 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
4. OCT and OCTA scans not meeting quality criteria at baseline
5. Inability to cooperate with study procedures
6. Inability to commit to the study visits
21 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Oregon Health and Science University
OTHER
Responsible Party
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David Huang
Principal Investigator
Principal Investigators
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David Huang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Casey Eye Institute - Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Chinmay Deshpande, MS Optom
Role: primary
Denzil Romfh, OD
Role: backup
Other Identifiers
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OHSU IRB0029104
Identifier Type: -
Identifier Source: org_study_id