NCT04704531

Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease.

Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution Applied in Three Different Dosage Schemes as Treatment for Mild to Moderate Dry Eye

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II, comparative, controlled, multicenter, parallel group, open, randomized clinical study. The main outcome variable will be the Ocular Surface Disease Index (OSDI) questionnaire. Three dosage schemes of topical ophthalmic application of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%; preservative free) are to be evaluated in patients diagnosed with mild to severe dry eye. Each group will be exposed to one of the following administration schemes: 1 drop bis in die (BID), 1 drop quater in die (QID), or 1 drop six times per day; instillation will take place in both eyes (OU).

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)	Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
DRUG	Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)	Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
DRUG	Sodium Hyaluronate Ophthalmic 0.4% Six times per day	Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.

Timeline

• Start date: 2022-01-03
• Primary completion: 2022-06-08
• Completion: 2022-06-08
• First posted: 2021-01-11
• Last updated: 2026-03-03
• Results posted: 2026-03-03

Locations

1 site across 1 country: Mexico