Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (PRO-037)

Phase IV Clinical Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo for Corneal Re-epithelialization After Photorefractive Keratectomy (PRK)

Phase IV comparative, controlled, parallel group, open, randomized multicenter study to evaluate the efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo. Primary outcome measure is the time of corneal re-epithelialization after PRK surgery. Intervention includes administration of one of the experimental products quater per die (QID) for 14 days.

Study Overview

• Status: Completed
• Conditions: Photorefractive Keratectomy; Corneal De-epithelialization
• Intervention / Treatment: Drug: Sodium Hyaluronate Ophthalmic 0.4%; Drug: Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Aris Vision Institute de Guadalajara, S. C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - Age ≥ 18 and ≤ 45 years old
• Being on PRK postoperative day 1 (right eye will be evaluated for efficacy)
• Presenting a PRK surgical corneal ablation surface of 5.5 to 6.0 mm
• PRK corneal output ≤ 60 µm
• Preoperative refraction of -1.0 to -4.5 D of myopia or myopic astigmatism (in this case, the sum of both values with a spherical equivalent no greater than -4.5 D)
• 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.
• Being willing and able to modify the required lifestyle activities.
• 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.

Exclusion Criteria:

• Having suffered any complications during and after PRK surgical procedure previous to inclusion in the study.
• Use of mitomycin during PRK
• Being subjected to PRK retreatment of previous history of any other kind of refractive surgery.
• 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.

• Diagnosis of any of the following:

  • Allergic, viral or bacterial conjunctivitis
  • Dry eye
  • Anterior blepharitis
  • Parasite infestation of ocular structures (Demodex, for example)
  • Previous history of ocular herpes
  • Previous history of ocular inflammation (such as uveitis)
  • Corneal or conjunctival ulcers
  • Glaucoma
• Previous history of drug addiction within the last 2 years previous 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.
• Previous history of any medical affliction, acute or chronic (such as Diabetes Mellitus type I/II, autoimmune diseases or HIV), 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.
• Use of medications (such as retinoic acid) that according to the investigator's criteria 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Lagricel® Ofteno PF; Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.	Drug: Sodium Hyaluronate Ophthalmic 0.4%; Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.; Other Names: PRO-037; Lagricel® Ofteno PF
Active Comparator: Group 2; Thealoz® Duo; Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.	Drug: Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%; Topical ophthalmic administration of one drop of Thealoz® Duo QID.; Other Names: Thealoz® Duo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Corneal Re-epithelialization (Time)	Corneal re-epithelialization will be evaluated through direct observation and photographic recording after application of fluorescein stain. After instillation of a drop of topical anesthetic (tetracaine 0.5%) a fluorescein strip will be applied on the inferior cul de sac while the patient looks upward. Using a slit lamp with magnification of 6x and 16x photographs (at least 6 images for each magnification) will be obtained.	Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)
Best Corrected Visual Acuity (BCVA)	(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: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Ocular Comfort Index	Ocular Comfort Index (OCI) Questionnaire will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.	Days: 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)
Pain Perception	Through a questionnaire, patients will be directly questioned about presence and severity of pain and associated symptoms. The scale will be as follows for severity: absent (0), very mild (1), mild (2), moderate (3) and severe (4)	Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)
Frequency of Pain Perception	Through a questionnaire, patients will be directly questioned about presence, severity and frequency of pain and associated symptoms. The scale will be as follows for frequency: never (0), almost never (1), 50% of the time (2), almost all the time (3) and all the time (4).	Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)
Unexpected Adverse Events (AEs) Related to the Investigational Product	The number of unexpected adverse events related to the investigational product that were recorded in each treatment group is described	Day: 17 (± 1) (safety call)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2022
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

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): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Carbohydrates; Polysaccharides; Disaccharides; Oligosaccharides; Sugars; Glucans; Trehalose
• Other Study ID Numbers: SOPH037-0120/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