Ocular Sequelae in Lyell syndrome
Conditions
Brief summary
The primary efficacy endpoint of this study is the change in tear film break-up time (TBUT), measured in seconds, between baseline (Day 0) and post-treatment follow-up visits, Secondary efficacy endpoints will consist of patient-reported outcome measures designed to capture the subjective impact of treatment on ocular symptoms and vision-related quality of life.
Detailed description
Clinical Safety Monitoring, Patient-Reported Tolerability via DL-QI
Interventions
Sponsors
TOXILYON
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint of this study is the change in tear film break-up time (TBUT), measured in seconds, between baseline (Day 0) and post-treatment follow-up visits, Secondary efficacy endpoints will consist of patient-reported outcome measures designed to capture the subjective impact of treatment on ocular symptoms and vision-related quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Safety Monitoring, Patient-Reported Tolerability via DL-QI | — |
Countries
France
Outcome results
None listed