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

Phase 4RecruitingNCT07217678

University of Miami20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Open-Angle Glaucoma Ocular Hypertension Glaucoma Suspect

Interventions

Durysta, Bimatoprost Intracameral Implant 10 µgDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bascom Palmer Eye Institute

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Caspase-1 mRNA Expression Following Durysta Injection

The primary outcome is evaluating whether the level of caspase-1 from the ocular surface changes after the Durysta injection when the number of topical medications is reduced. Higher values indicate more inflammation, while lower values indicate less information and a more stable ocular surface. The Caspase-1 level will be measured using RT-PCR.

Time frame: Baseline, post-injection 1 month, post-injection 3 months

Secondary Outcomes

Change in Corneal Sensitivity Following Durysta Injection

Change in corneal tactile sensitivity from measured using a non-contact esthesiometer (in sensitivity units). Greater sensitivity values indicate less ocular surface dysfunction; lower values reflect reduced sensitivity and potential surface.

Time frame: Baseline, post-injection 1 month, post-injection 3 months

Change in Ocular Pain Symptoms via Visual Analog Scale (VAS)

Change in patient-reported ocular pain symptoms from post-Durysta injection, assessed using a Visual Analog Scale (VAS). VAS scores range from 1 to 10, where higher scores indicate more severe pain and lower scores reflect minimal discomfort.

Time frame: Baseline, post-injection 1 month, post-injection 3 months

Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System

Change in corneal staining score post-Durysta injection, assessed using the National Eye Institute (NEI) grading system. This system evaluates five corneal regions-central, temporal, superior, nasal, and inferior-with each region scored from 0 to 3 based on fluorescein staining intensity. The total score ranges from 0 (no staining) to 15 (diffuse staining across all regions). Lower scores indicate improved ocular surface integrity and reduced epithelial damage; higher scores reflect more extensive surface compromise.

Time frame: Baseline, post-injection 1 month, post-injection 3 months

Central Contacts

Javier Paredes, BA, MBA

CONTACT

305-326-6387 jxp2537@med.miami.edu

Monica Arango, BA

CONTACT

305-326-6351 mrarango@med.miami.edu

Data from ClinicalTrials.gov

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