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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Glaucoma Open-Angle Glaucoma Ocular Hypertension Glaucoma Suspect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Durysta

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

Group Type EXPERIMENTAL

Durysta, Bimatoprost Intracameral Implant 10 µg

Intervention Type 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.

Interventions

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Durysta, Bimatoprost Intracameral Implant 10 µg

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No