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Safety of TRS01 in Post-surgical Ocular Inflammation
NCT04222725Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2020
- Primary completion
- Jul 2020
- Countries
- 1
- Sponsor
- Tarsier Pharma
- Modality
- Peptides, Small Molecules
- Drugs
- dazdotuftide
- Conditions
- ocular inflammation
01
Overview
Phase 2, randomised, double-blind trial of dazdotuftide in ocular inflammation (4 arms), sponsored by Tarsier Pharma. Primary endpoint: Assessment of Both Systemic and Ocular Adverse Events at 14 days. Started Feb 2020; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
TRS01 Low Dose
TRS01 eye drops QID
TRS01 Medium Dose
TRS01 eye drops QID
TRS01 High Dose
TRS01 eye drops QID
Placebo
Vehicle eye drops QID
03
Who it enrols
Adult patients undergoing routine cataract surgery who develop post-surgical inflammation (AC cells >= grade 2) on day 1 post-op.
04
Endpoints
Primary
Assessment of Both Systemic and Ocular Adverse Events
Secondary
Anterior Chamber Cell Clearing
Ocular Pain Reduction
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