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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03442751 | Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus | PHASE3 | COMPLETED | 201 | — | — | Apr 6, 2018 | Aug 10, 2020 | Jan 30, 2024 | 1 | United States |
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
| Arm | Type | Description |
|---|---|---|
| Epithelium-on CXL Treatment Group | EXPERIMENTAL | Study eye receives Test Article A, Test Article B, and exposed to cross-linking dose of UVA light generated by the KXL medical device system |
| Sham Treatment/Control Group | SHAM_COMPARATOR | Sham eye receives Placebo and and exposed to mock dose of UVA light generated by the KXL medical device system |
| Name | Type | Description |
|---|---|---|
| Test Article A | DRUG | Riboflavin Ophthalmic Solution A |
| Test Article B | DRUG | Riboflavin Ophthalmic Solution B |
| Placebo | DRUG | Placebo Vehicle of Test Article |
| KXL medical device system | DEVICE | Mock UVA light source |
Inclusion Criteria: 1. Be between 12 and 55 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) will need to sign an assent form as well as havi...