Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Status:
Completed
Trial end date:
2019-11-13
Target enrollment:
Participant gender:
Summary
Study design: Phase I clinical trial, single-center, controlled, parallel group, open,
randomized.
Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes).
Estimated duration of the study: 5 months
Therapeutic indication: Eye lubricant Use: Dry Eye
Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured
by Laboratorios Sophia on the ocular surface of clinically healthy subjects.
Hypothesis:
H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile
similar to Lagricel® Ofteno single dose in healthy subjects.
H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability
profile than Lagricel® Ofteno single dose in healthy subjects.
Main inclusion criteria: Clinically healthy subjects