32
Participants
Start Date
July 25, 2018
Primary Completion Date
November 8, 2018
Study Completion Date
April 2, 2019
USB005 (aclerastide) Ophthalmic Solution
Aclerastide (\[Nle3\]-Angiotensin II (1-7)) is aseptically formulated in USB005 Ophthalmic Solution for topical ophthalmic administration. Active pharmaceutical ingredient (API) levels ranging from 0.03% to 0.45% are formulated in a sterile vehicle consisting of 0.06% Sodium Phosphate Monobasic Anhydrous, USP; 3% Glycerol, USP; 1.4% Polyvinyl Alcohol, USP; and 0.5% Hydroxyethylcellulose (HEC 250 HHX), NF in Sterile Water for Injection, USP.
USB005 Ophthalmic Solution Placebo
A clinical placebo formulated with the same excipients and packaged in the same container closure system as the active product, USB005 (aclerastide) Ophthalmic Solution.
WCCT Global, Inc., Cypress
United States Department of Defense
FED
US Biotest, Inc.
INDUSTRY