Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease. (PRO-037)

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

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Sodium Hyaluronate Ophthalmic 0.4% Six times per day; Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID); Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Instituto Jalisciense del Metabolismo, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years old.
• Being capable of voluntarily grant a signed informed consent.
• Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
• Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.

• Presenting a mild to moderate dry eye disease diagnosis, defined as:

  • OSDI score between 13 and 32, plus one of the following:

    • More than 5 dots of corneal staining
    • More than 9 dots of conjunctival staining
    • Tear Break-up Time (BUT) < 10 seconds

Exclusion Criteria:

• Pregnancy, breastfeeding or planning to become pregnant during the time of the study
• Having participated in clinical trials within 30 days prior to signing this study's informed consent form.
• Having participated previously in this study.
• Best Corrected Visual Acuity (BCVA) equal or worse than 20/200, in either eye.

• Diagnosis of any of the following:

  • Allergic, viral or bacterial conjunctivitis
  • Anterior blepharitis
  • Parasite infestation of ocular structures (Demodex, for example)
  • Unresolved history of ocular trauma
  • Scarring diseases of the ocular surface
  • Corneal or conjunctival ulcers
  • Filamentary keratitis
  • Neurotrophic keratitis
  • Bullous keratopathy
  • Neoplastic diseases of the ocular surface or ocular annexes
  • Diseases presenting fibrovascular proliferations on the corneal or conjunctival surface.
  • Any retinal or posterior segment diseases that require treatment or threat the visual outcome.
  • Glaucoma
• Requiring management for dry eye that includes implementation of treatments described in the step 2 management recommendations of the Tear Film & Ocular Surface Society's Dry Eye Work Shop II (TFO DEWS II).
• Previous history of drug addiction within the last 2 years prior to signing this study's informed consent form.
• Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.
• Being a contact lens user, rigid or soft. Inclusion is possible if the use of contact lenses is suspended both during the study period and at least 15 days prior inclusion takes place.
• Previous history of any medical affliction, acute or chronic, that according to the investigator may increase either the risk to the patient for participating in this study or the risk of interference of the accurate interpretation of results.
• Known hypersensitivity to any of the components of the products used in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 3; Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.	Drug: Sodium Hyaluronate Ophthalmic 0.4% Six times per day; Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.; Other Names: PRO-037; Lagricel® Ofteno
Experimental: Group 1; Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop twice a day (BID) in both eyes (OU) during 30 days.	Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID); Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.; Other Names: PRO-037; Lagricel® Ofteno
Experimental: Group 2; Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop four times a day (QID) in both eyes (OU) during 30 days.	Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID); Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.; Other Names: PRO-037; Lagricel® Ofteno

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ocular Surface Disease Index (OSDI)	OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.	Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).
Incidence of Adverse Events (AE)	Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution and whether it was considered related or not to the investigation products.	Up to Day 33 (+ 1) (safety call).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tear Break-up Time (BUT)	After application of fluorescein stain, using a slit lamp and its cobalt blue filter, the time elapsed after instructing the patient to blink 1 or 2 times and the appearance of dry spots on the ocular surface will be counted and reported as BUT. Normally, this parameter is ≥ 10 seconds.	Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Change in Conjunctival and Corneal Staining With Lissamine Green	The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).	Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Change in Conjunctival and Corneal Staining With Fluorescein	The evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).	Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Change in Conjunctival Hyperemia	Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (III), and Severe (IV).	Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Incidence of Chemosis	Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent. This evaluation will be made taking in consideration the counts of "absent" seen per counts of eyes and per visit.	Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Change in Best Corrected Visual Acuity (BCVA)	With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc. The normal score for a VA is 20/20.This score is expressed in decimal (i.e. 1.0) format. In decimal format, a lower number is a worse outcome.	Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Change in Intraocular Pressure (IOP)	Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP will be evaluated. Normal values are considered between 10 and 21 mmHg.	BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit).

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): June 8, 2022
• Study Completion (Actual): June 8, 2022

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; BID protein, human
• Other Study ID Numbers: SOPH037-1219/II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No