Rocklatan Retinal Perfusion OCT Study

NCT ID: NCT07174401

Last Updated: 2025-12-24

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Keywords

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Glaucoma Rocklatan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The investigator will assign one eye to use the study drug, while the other eye (control) will remain on the clinically prescribed medication. The identity of the eye drop will be masked to both participants and study personnel who perform testing procedures or data analysis. The university research pharmacy will provide label masked bottles for each eye.

Study Groups

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Eye with Diagnosed Glaucoma

Group Type EXPERIMENTAL

Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months.

Intervention Type 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.

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with both eyes with open angle glaucoma.
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

1. Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit
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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

Central Contacts

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Chinmay Deshpande, MS Optom

Role: CONTACT

Phone: 503-494-9628

Email: [email protected]

Denzil Romfh, OD

Role: CONTACT

Phone: 503-494-4351

Email: [email protected]

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