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

NCT04704531 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-03-03

Study results available
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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

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.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2022-06-08
Completion
2022-06-08

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704531 on ClinicalTrials.gov