Glaucoma, Glaucoma Suspect, Ocular Hypertension, Open-Angle Glaucoma
Conditions
Brief summary
The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
Interventions
Participants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg). Participants will be followed by a total of 3 months.
Sponsors
University of Miami
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eye with open-angle glaucoma or suspected of open-angle glaucoma * Pseudophakic in eye of interest with Shafer grading ≥3 * ≤ 3 daily applications of topical glaucoma medications for ≥6 months (of which one is a nightly preserved PGA) * Good adherence to medication regimen - screening questions to be asked of potential subject: * In the last month, what percentage of the time would you estimate missing the application of drops? (Must be ≤20%) * When was the last administration? (Last dose must have been within last 24 hours) * Presence of punctate epithelial erosions in the cornea (NEI scale \> 3)
Exclusion criteria
* Retinal disease (e.g., wet age-related macular degeneration, proliferative diabetic retinopathy, central retinal vein occlusion) * Use of topical or systemic immunosuppressor or immunomodulator drug (e.g., steroids, cyclosporine, lifitegrast, or antihistamines) * Use of preservative-free hypotensive medications * Any clinical contraindications to receiving intracameral bimatoprost implantation * History of recurrent conjunctivitis (e.g., allergic or atopic conjunctivitis) * History of partial or full corneal transplant * History of ophthalmic surgery (intraocular or tarsus-involving oculoplastic procedures) within last 6 months * History of subconjunctival glaucoma surgery (i.e., trabeculectomy, aqueous shunt, Xen implant) within last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caspase-1 mRNA Expression Following Durysta Injection | Baseline, post-injection 1 month, post-injection 3 months | The primary outcome is evaluating whether the level of caspase-1 from the ocular surface changes after the Durysta injection when the number of topical medications is reduced. Higher values indicate more inflammation, while lower values indicate less information and a more stable ocular surface. The Caspase-1 level will be measured using RT-PCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Corneal Sensitivity Following Durysta Injection | Baseline, post-injection 1 month, post-injection 3 months | Change in corneal tactile sensitivity from measured using a non-contact esthesiometer (in sensitivity units). Greater sensitivity values indicate less ocular surface dysfunction; lower values reflect reduced sensitivity and potential surface. |
| Change in Ocular Pain Symptoms via Visual Analog Scale (VAS) | Baseline, post-injection 1 month, post-injection 3 months | Change in patient-reported ocular pain symptoms from post-Durysta injection, assessed using a Visual Analog Scale (VAS). VAS scores range from 1 to 10, where higher scores indicate more severe pain and lower scores reflect minimal discomfort. |
| Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System | Baseline, post-injection 1 month, post-injection 3 months | Change in corneal staining score post-Durysta injection, assessed using the National Eye Institute (NEI) grading system. This system evaluates five corneal regions-central, temporal, superior, nasal, and inferior-with each region scored from 0 to 3 based on fluorescein staining intensity. The total score ranges from 0 (no staining) to 15 (diffuse staining across all regions). Lower scores indicate improved ocular surface integrity and reduced epithelial damage; higher scores reflect more extensive surface compromise. |
Countries
United States
Contacts
CONTACTJavier Paredes, BA, MBA
CONTACTMonica Arango, BA
PRINCIPAL_INVESTIGATORSwarup S Swaminathan, MD
University of Miami
Outcome results
None listed