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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
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34 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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