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

Conditions

• Corneal Scar

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 5, 2024

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CSB-001 QID
  One drop CSB-001 four times daily for 14 days in the study eye
• Experimental: CSB-001 TID
  One drop CSB-001 three times daily for 14 days in the study eye

Primary Outcome Measure

Safety as Assessed by Adverse Event Reporting [ Time Frame: Day 1 through Day 56 ]

Central Contacts

• Central Operations Representative
  949-354-1299
  [email protected]

Locations (7)

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