NCT07217678 Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
| NCT ID | NCT07217678 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Miami |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-09 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2026-02-09 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Swarup S Swaminathan, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07217678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07217678 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07217678 currently recruiting?
Yes, NCT07217678 is actively recruiting participants. Contact the research team at jxp2537@med.miami.edu for enrollment information.
Where is the NCT07217678 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07217678 clinical trial?
NCT07217678 is sponsored by University of Miami. The principal investigator is Swarup S Swaminathan, MD at University of Miami. The trial plans to enroll 20 participants.