Eye-surface inflammation after replacing nightly preserved glaucoma drops with a Durysta implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.