RecruitingPhase 4NCT07217678

Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use

Sponsor

University of Miami

Enrollment

20 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

Open Angle Glaucoma Glaucoma Ocular Hypertension Glaucoma, Suspect

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria8

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

DRUGDurysta, Bimatoprost Intracameral Implant 10 µg

Participants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg). Participants will be followed by a total of 3 months.