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

NCT07217678 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20240111
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  Baseline, post-injection 1 month, post-injection 3 months

Secondary Outcomes (3)

• Change in Corneal Sensitivity Following Durysta Injection

  Baseline, post-injection 1 month, post-injection 3 months

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

  Baseline, post-injection 1 month, post-injection 3 months

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

  Baseline, post-injection 1 month, post-injection 3 months

Study Arms (1)

Durysta

EXPERIMENTAL

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

Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

Interventions

Durysta, Bimatoprost Intracameral Implant 10 µg DRUG

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.

Durysta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• AbbVie: collaborator

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33134, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Swarup S Swaminathan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Paredes, BA, MBA

CONTACT

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

Monica Arango, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 16, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)