Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
In the last month, what percentage of the time would you estimate missing the application of drops? (Must be ≤20%)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Durysta, Bimatoprost Intracameral Implant 10 µg
DrugParticipants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg). Participants will be followed by a total of 3 months.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: DurystaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
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University of Miami
Lead sponsor
AbbVie
Collaborator
Source ClinicalTrials.gov