Blepharitis due to Demodex infestation Eye Diseases Blepharitis
Conditions
Interventions
A post-treatment observational study to follow participants who were previously treated for 43 days with TP-03, 0.25% or its vehicle. Participants will be assessed at 180 and 365 days following the in
Sponsors
Tarsus Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged =18 years of age 2. Participants must have been treated with TP-03 or the vehicle of TP-03 for 43 days 3. Be willing to sign IRB-approved informed consent and deemed capable of complying with the requirements of the study protocol 4. Be willing to forego participation in any clinical trial with an investigational drug or device during the observational study
Exclusion criteria
Exclusion criteria: The investigator has the right to exclude any individual from participating in the study if s/he deems it in the best interest of the participant or if the participant’s enrollment could impact data validity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events assessed using participant response to non-specific queries, spontaneous participant reports and investigator observations at Day 180 and Day 365 | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, Day 180 and Day 365: 1. Visual acuity measured using ETDRS-Fast method 2. Anterior segment health assessed using slit-lamp biomicroscopy 3. Intraocular pressure measured using applanation tonometry 4. Posterior segment health assessed using dilated fundus examination | — |
Countries
United States of America
Contacts
Public ContactYesha Raval
Outcome results
None listed