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

University of Miami

Status and phase: Not yet enrolling; Phase 4

Conditions: Open-Angle Glaucoma; Glaucoma; Ocular Hypertension; Glaucoma Suspect

Treatments: Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07217678

20240111

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Durysta

Experimental group

Description:

Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg

Treatment:

Drug: Durysta, Bimatoprost Intracameral Implant 10 µg