Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Miami
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Caspase-1 mRNA Expression Following Durysta Injection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Durysta
Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg
Intervention: Durysta, Bimatoprost Intracameral Implant 10 µg (Drug)
Outcomes
Primary Outcomes
Change in Caspase-1 mRNA Expression Following Durysta Injection
Time Frame: 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 Outcomes
- Change in Corneal Sensitivity Following Durysta Injection(Baseline, post-injection 1 month, post-injection 3 months)
- Change in Ocular Pain Symptoms via Visual Analog Scale (VAS)(Baseline, post-injection 1 month, post-injection 3 months)
- Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System(Baseline, post-injection 1 month, post-injection 3 months)
Investigators
Swarup Swaminathan
Associate Professor of Ophthalmology
University of Miami