Eye-surface inflammation after replacing nightly preserved glaucoma drops with a Durysta implant
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
We will try a single Durysta intracameral implant to see if cutting back nightly preserved glaucoma drops reduces eye-surface inflammation in people with open-angle glaucoma or ocular hypertension who are pseudophakic and have signs of surface damage.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07217678 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study gives a single bimatoprost intracameral implant (Durysta 10 µg) and reduces topical glaucoma medication to determine effects on ocular surface inflammation. Inflammation will be measured using levels of caspase-1, an inflammatory biomarker, alongside standard corneal staining assessments. Eligible participants are pseudophakic in the study eye, have punctate epithelial erosions (NEI scale > 3), and have used up to three daily topical glaucoma medications for at least six months, including a nightly preserved prostaglandin analogue. Key exclusions include retinal disease, use of topical or systemic immunosuppressants or immunomodulators, and current use of preservative-free hypotensive drops. The study is conducted at Bascom Palmer Eye Institute (University of Miami) with collaboration from AbbVie.
Who should consider this trial
Good fit: Ideal candidates are people with open-angle glaucoma, ocular hypertension, or glaucoma suspect who are pseudophakic in the study eye, have corneal punctate epithelial erosions (NEI > 3), have been on ≤3 daily topical glaucoma medications for ≥6 months including a nightly preserved PGA, and demonstrate good drop adherence (≤20% missed doses, last dose within 24 hours).
Not a fit: Patients with retinal disease, those using topical or systemic immunosuppressive/immunomodulatory medications, those already using preservative-free glaucoma drops, or those with contraindications to the implant may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, replacing nightly preserved drops with a Durysta implant could lower ocular-surface inflammation and improve eye comfort and quality of life by reducing exposure to preserved topical medications.
How similar studies have performed: Durysta (bimatoprost intracameral implant) has been shown in prior trials to lower intraocular pressure and reduce reliance on topical drops, but using it specifically to lower ocular-surface inflammation measured by caspase-1 is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- Bascom Palmer Eye Institute — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Swarup S Swaminathan, MD — University of Miami
- Study coordinator: Javier Paredes, BA, MBA
- Email: jxp2537@med.miami.edu
- Phone: 305-326-6387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.