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NCT Number: NCT07217678

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma Suspect Glaucoma, Open-Angle Ocular Hypertension Open-angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Caspase-1 mRNA Expression Following Durysta Injection

    Time frame: 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 outcomes

  1. Change in Corneal Sensitivity Following Durysta Injection

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Paredes, BA, MBA

CONTACT

[email protected]

305-326-6387

Monica Arango, BA

CONTACT

[email protected]

305-326-6351

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • AbbVie

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 16, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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