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

Not Applicable

Not yet recruiting

• Conditions: Glaucoma; Open-Angle Glaucoma; Ocular Hypertension; Glaucoma Suspect
• Interventions: Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

• Registration Number: NCT07217678
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-14
• Study First Submitted QC: 2025-10-14
• Last Update Submitted: 2025-10-14
• Study First Posted: 2025-10-16
• Last Update Posted: 2025-10-16
• Study Start: 2026-01-31
• Primary Completion: 2028-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durysta	Durysta, Bimatoprost Intracameral Implant 10 µg	Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg

Primary Outcome Measures

Name	Time	Method
Change in Caspase-1 mRNA Expression Following Durysta Injection	Baseline, post-injection 1 month, post-injection 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Corneal Sensitivity Following Durysta Injection	Baseline, post-injection 1 month, post-injection 3 months	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.
Change in Ocular Pain Symptoms via Visual Analog Scale (VAS)	Baseline, post-injection 1 month, post-injection 3 months	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.
Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System	Baseline, post-injection 1 month, post-injection 3 months	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.

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States