NCT07217678PHASE4Recruiting
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
University of Miami
Start Date
2/9/2026
Completion Date
1/31/2028
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
Age Range: 18 years to No maximum
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
Interventions
DRUG
Durysta, Bimatoprost Intracameral Implant 10 µg
Conditions
GlaucomaOpen-Angle GlaucomaOcular HypertensionGlaucoma Suspect
Locations
Bascom Palmer Eye Institute
Miami, Florida 33134
United States