Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye. (PRO-087)

Non Inferiority Phase IV Clinical Study, to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF Against Hyabak® and Lagricel Ofteno® PF When Applied on the Ocular Surface of Patients With Mild to Moderate Dry Eye.

Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%; Drug: Sodium hyaluronate 0.15%; Drug: Sodium hyaluronate 0.4%

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44190
      • Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Age ≥ 18 years old
• 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 ≥ 13, plus one of the following:

    • More than 5 dots of corneal staining
    • More than 9 dots of conjunctival staining
    • Tear break-up time < 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 the eligibility visit.
• Having participated previously in this study.
• 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 any ocular or annex 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
  • Any palpebral alteration that causes eyelid malposition, limiting the adequate closure or aperture of this structures, or that cause tearing.
• 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: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Humylub Ofteno® PF; Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.	Drug: Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%; Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.; Other Names: Humylub Ofteno® PF; PRO-087
Active Comparator: Arm 2; Hyabak®; Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.	Drug: Sodium hyaluronate 0.15%; Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.; Other Names: Hyabak® PF
Active Comparator: Arm 3; Lagricel Ofteno® PF; Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.	Drug: Sodium hyaluronate 0.4%; Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.; Other Names: Lagricel Ofteno® PF; PRO-037

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ocular Surface Disease Index (OSDI)	OSDI is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.	Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninvasive Keratograph Break-up Time (NIKBUT)	This evaluation will be performed through an Oculus Keratograph 5M, and the parameter "first break-up time" will be recorded as NIKBUT. A lower value is a worse outcome. This outcome measure considered the Per Protocol (PP) population.	Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change of Conjunctival and Corneal Staining With Lissamine Green	The change in proportion of participant's abscence of conjunctival and corneal staining with lissamine green will be analyzed. 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). This outcome measure considered the Per Protocol (PP) population.	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change of Conjunctival and Corneal Staining With Fluorescein	The change in proportion of participant's abscence of conjunctival and corneal staining with fluorescein will be analyzed. 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). This outcome measure considered the Per Protocol (PP) population.	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change in Conjunctival Hyperemia	The change in proportion of participant's score will be analyzed. Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4). This outcome measure considered the Per Protocol (PP) population.	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Incidence of Related Non Expected Adverse Events	Number of related non expected adverse events observed per group. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.	Days: 0 (eligibility visit), 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), 31 - 33 (± 1) (final visit), and 38 - 40 (± 1) (safety call).
Change in 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 per subject. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
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 (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. Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20. This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.	Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Munoz-Villegas P, Garcia-Sanchez G, Jauregui-Franco RO, Quirarte-Justo S, Sanchez-Rios A, Olvera-Montano O. Influence of Environmental Factors with Clinical Signs and Symptoms in the Management of Dry Eye Disease. Clin Ophthalmol. 2024 Aug 30;18:2439-2451. doi: 10.2147/OPTH.S480223. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 3, 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; Carbohydrates; Glycosaminoglycans; Polysaccharides; Hyaluronic Acid
• Other Study ID Numbers: SOPH087-0120/IV

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