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Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use

NCT07217678 · University of Miami
In plain English

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About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-09
Estimated completion: 2028-01-31
Last updated: 2026-03-05
Interventions
Drug: Durysta, Bimatoprost Intracameral Implant 10 µg
Primary outcomes
  • Change in Caspase-1 mRNA Expression Following Durysta Injection (Baseline, post-injection 1 month, post-injection 3 months)
Sponsor
University of Miami · other
With: AbbVie
Contacts & investigators
ContactJavier Paredes, BA, MBA · contact · jxp2537@med.miami.edu · 305-326-6387
ContactMonica Arango, BA · contact · mrarango@med.miami.edu · 305-326-6351
InvestigatorSwarup S Swaminathan, MD · principal_investigator, University of Miami
All locations (1)
Bascom Palmer Eye InstituteRecruiting
Miami, Florida, United States
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use · TrialPath