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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Change in Caspase-1 mRNA Expression Following Durysta Injection [Срок оценки: Baseline, post-injection 1 month, post-injection 3 months]

Вторичные конечные точки (3)

• Change in Corneal Sensitivity Following Durysta Injection [Срок оценки: Baseline, post-injection 1 month, post-injection 3 months]
• Change in Ocular Pain Symptoms via Visual Analog Scale (VAS) [Срок оценки: Baseline, post-injection 1 month, post-injection 3 months]
• Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System [Срок оценки: Baseline, post-injection 1 month, post-injection 3 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Bascom Palmer Eye Institute — Miami

Идентификаторы

NCT: NCT07217678 · 20240111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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