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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Durysta, 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.

Locations (1)

Bascom Palmer Eye Institute
Miami, Florida, United States