Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars

Официальное название

A Two-Arm Open-Label Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars

Обзор

This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.

Вмешательства

• Биопрепарат CSB-001 Ophthalmic Solution 0.1%
  CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Первичные конечные точки

• Safety as Assessed by Adverse Event Reporting [Срок оценки: Day 1 through Day 56]
• Safety as Assessed by Slit-lamp Biomicroscopy [Срок оценки: Screening through Day 56]
• Safety as Assessed by Best-Corrected Distance Visual Acuity [Срок оценки: Screening through Day 56]

Вторичные конечные точки (6)

• Efficacy as Assessed by Area of Corneal Scar [Срок оценки: Screening through Day 56]
• Efficacy as Assessed by Maximum Depth of Cornea Scar [Срок оценки: Screening through Day 56]
• Efficacy as Assessed by Volume of Scar [Срок оценки: Screening through Day 56]
• Efficacy as Assessed by Density of Scar [Срок оценки: Screening through Day 56]
• Efficacy as Assessed by Contrast Sensitivity [Срок оценки: Screening through Day 56]
• Efficacy as Assessed by Distance Visual Acuity [Срок оценки: Screening through Day 56]

Критерии участия

Критерии включения

• Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision.
• Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.
• Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.
• Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea.
• Subjects must have the ability and willingness to comply with study procedures.

Критерии исключения

• Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.
• Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.
• No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.
• Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active.
• Ocular surgery planned during the study treatment period.
• Presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.

Note: Other inclusion/exclusion criteria apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Loma Linda University Eye Institute — Loma Linda
• Midwest Cornea Associates, LLC — Carmel
• Francis Price Jr, MD — Indianapolis
• Minnesota Eye Consultants — Minnetonka
• Legacy Devers Eye Institute — Portland
• Stuart A. Terry, MD PA — San Antonio
• Virginia Eye Consultants — Norfolk

Идентификаторы

NCT: NCT06257355 · CSB-C23-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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