Dose escalation 3+3 design with accelerated titration 4 dose levels
This is a 28-day open-label dose-escalation study. TTHX1114(NM141) Ophthalmic Solution: 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days. Four planed dose levels, accelerated titration DL1 and DL2, standard 3+3 design.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
8
Eye drop twice daily
Trefoil Clinical Site #132
Cypress, California, United States
Dose Limiting Toxicity
Important Medical Events (ocular) related to study treatment
Time frame: 28 days
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