Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects
Public ClinicalTrials.gov record NCT04909450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.
Study identification
- NCT ID
- NCT04909450
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 131 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2021 (Actual)
- Primary completion
- May 7, 2024 (Actual)
- Completion
- Jun 4, 2024 (Actual)
- Last update posted
- May 13, 2026
2021 – 2024
United States locations
- U.S. sites
- 45
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eye Care North | Cave Creek | Arizona | 85331 | — |
| Loma Linda University Eye Institute | Loma Linda | California | 92354 | — |
| Nvision Clinical Research, LLC | Los Angeles | California | 90013 | — |
| Global Research Foundation | Los Angeles | California | 90041 | — |
| UCLA Stein Eye Institute | Los Angeles | California | 90095 | — |
| LoBue Laser and Eye Medical Center, Inc. | Murrieta | California | 92562 | — |
| California Eye Specialists Medical Group Inc. | Pasadena | California | 91107 | — |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | — |
| Gordon Schanzlin New Vision Institute | San Diego | California | 92122 | — |
| Atlantis Eyecare | Torrance | California | 90505 | — |
| University of Colorado - Dept. of Ophthalmology | Aurora | Colorado | 80045 | — |
| Vision Institute | Colorado Springs | Colorado | 80907 | — |
| Corneal Consultants of Colorado | Littleton | Colorado | 80120 | — |
| Advanced Research | Boynton Beach | Florida | 33437 | — |
| Bowden Eye and Associates | Jacksonville | Florida | 32256 | — |
| International Eye Associates, PA | Ormond Beach | Florida | 32174 | — |
| Bascom Palmer Eye Institute at Palm Beach Gardens | Palm Beach | Florida | 33418 | — |
| International Research Center | Tampa | Florida | 33603 | — |
| Eye Consultants of Atlanta | Atlanta | Georgia | 30339 | — |
| Midwest Cornea Associates, LLC | Carmel | Indiana | 46290 | — |
| Price Vision Group | Indianapolis | Indiana | 46260 | — |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | — |
| Kentucky Eye Institute | Lexington | Kentucky | 40517 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Cornea and Contact Lens Institute of Minnesota | Edina | Minnesota | 55436 | — |
| Minnesota Eye Consultants | Minnetonka | Minnesota | 55305 | — |
| Tauber Eye Center | Kansas City | Missouri | 64111 | — |
| Ophthalmology Associates | St Louis | Missouri | 63131 | — |
| Metropolitan Eye Research and Surgery Institute | Palisades Park | New Jersey | 07650 | — |
| SightMD | Babylon | New York | 11702 | — |
| Cornea Consultants of Albany | Slingerlands | New York | 12159 | — |
| Duke Eye Center | Durham | North Carolina | 27710 | — |
| Eye Consultants of North Dakota | Fargo | North Dakota | 58104 | — |
| The Ohio State University, Department of Ophthalmology and Visual Sciences | Columbus | Ohio | 43212 | — |
| Devers Eye Institute | Portland | Oregon | 97210 | — |
| Hazleton Eye Specialists | Hazle Township | Pennsylvania | 18202 | — |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | — |
| Carolina Cataract & Laser Center | Ladson | South Carolina | 29456 | — |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | — |
| BLINK Research Center, LLC | Memphis | Tennessee | 38119 | — |
| University of Texas at Austin; The Mitchel and Shannon Wong Eye Institute | Austin | Texas | 78712 | — |
| Stuart A. Terry, MD PA | San Antonio | Texas | 78212 | — |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04909450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04909450 live on ClinicalTrials.gov.