Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects

Summary

Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects. Goals: To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis: The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.

Timeline

Start

2018-01-25

Primary completion

2018-05-25

Completion

2018-06-10

Outcome

Mixed primary results

registry NUMBER PRO-174: 11 adverse events NUMBER Sophixín Ofteno®: 10 adverse events analysis (non-inferiority test); PRO-174 vs Sophixín Ofteno®; p = 0.749; Wilcoxon (Mann-Whitney) NCT03519516 ↗

registry NUMBER PRO-174: Normal: 86.7 percentage of participants NUMBER Sophixín Ofteno®: Normal: 57.1 percentage of participants NCT03519516 ↗

registry analysis (non-inferiority test); PRO-174 vs Sophixín Ofteno®; p = 0.041; Chi-squared NCT03519516 ↗

Publications

• Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ciprofloxacin	Small molecule	1 unknown	Other
Subject	Levofloxacin	Small molecule	1 unknown	Other

Indications