NCT04081610

Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	lagricel ofteno multidose	* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic
DRUG	lagricel ofteno single dose	* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic

Timeline

• Start date: 2019-09-09
• Primary completion: 2019-10-23
• Completion: 2019-11-13
• First posted: 2019-09-09
• Last updated: 2021-05-03
• Results posted: 2021-05-03

Locations

1 site across 1 country: Mexico