Tests a sustained-release eye implant in people with glaucoma
Tests whether an eye implant reducing daily drops lowers eye surface inflammation in adults.
Plain-language title generated from the registry record
Registry title: Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Key facts
- Where
- Miami, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Bascom Palmer Eye InstituteMiami, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Miami
- Trial code
- NCT07217678
- Record updated
- 5 March 2026
- Original description
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.Read full original descriptionShow less
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
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.
Inclusion: 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: 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; Retinal disease (e.g., wet age-related macular degeneration, proliferative diabetic retinopathy, central retinal vein occlusion).