At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Compared to Lagricel® Ofteno Single Dose on the Ocular Surface of Clinically Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating lagricel ofteno multidose and lagricel ofteno single dose for Dry Eye. Completed, enrolled 34 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic
* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic