Glaucoma
Conditions
Keywords
Glaucoma, Rocklatan
Brief 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.
Interventions
DRUGRocklatan 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.
DEVICETwo 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.
Sponsors
Alcon Research
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nerve Fiber Layer Plexus Capillary Density (NFLP CD) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Retinal Blood Flow (TRBF) | From enrollment to end of treatment at 11-12 months | Secondary outcome measures will include change in the TRBF measured at 6 months or 11-12 month endpoint visits compared to baseline. |
Countries
United States
Contacts
Primary ContactChinmay Deshpande, MS Optom
Backup ContactDenzil Romfh, OD
Outcome results
None listed