Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05314738 | Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus | PHASE1 | RECRUITING | 150 | — | — | Mar 8, 2022 | Feb 1, 2026 | Jul 8, 2024 | 3 | United States |
Change in Kmax topography value from baseline
| Arm | Type | Description |
|---|---|---|
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1 | EXPERIMENTAL | Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A | ACTIVE_COMPARATOR | Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A | ACTIVE_COMPARATOR | Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A | ACTIVE_COMPARATOR | Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B | ACTIVE_COMPARATOR | Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B | ACTIVE_COMPARATOR | Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B | ACTIVE_COMPARATOR | Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 |
| Placebo Group 2 / Cohort 2B | SHAM_COMPARATOR | Sham Solution with no exposure to NXL System |
| Name | Type | Description |
|---|---|---|
| NXL Energy 1 | COMBINATION_PRODUCT | Riboflavin drops + NXL System to Total Energy Level 1 |
| NXL Energy 2 | COMBINATION_PRODUCT | Riboflavin drops + NXL System to Total Energy Level 2 |
| NXL Energy 3 | COMBINATION_PRODUCT | Riboflavin drops + NXL System to Total Energy Level 3 |
| Sham Treatment | COMBINATION_PRODUCT | Sham Drops and No exposure to NXL system |
Inclusion Criteria: * Provide written informed consent * Ability to hold gaze sufficiently stable for study testing * Willingness and ability to follow all instructions and comply with schedule for follow-up visits * Have a diagnosis of keratoconus Exclusion Criteria: * Known allergy or sensitivi...