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AzTrials

Photorefractive KeratectomyPhase 4PRO-037NCT04704518

Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy

A Phase 4 study testing Sodium Hyaluronate Ophthalmic 0.4% and Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15% in people with Photorefractive Keratectomy and Corneal De-epithelialization, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Sodium Hyaluronate Ophthalmic 0.4% and Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteMexico
Study dates
3 Sep 2022to 22 Dec 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • - 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Aris Vision Institute de Guadalajara, S. C.

    Guadalajara, Jalisco

Other trials in Mexico

About this study

Official title: 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.

Being tested
Sodium Hyaluronate Ophthalmic 0.4%, Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium Hyaluronate Ophthalmic 0.4%Drug

    Also called Lagricel® Ofteno PF, PRO-037

    Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.

  • Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%Drug

    Also called Thealoz® Duo

    Topical ophthalmic administration of one drop of Thealoz® Duo QID.

Study groups in NCT04704518
Study groupRoleWhat they receive
Group 1; Lagricel® Ofteno PFExperimentalLagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Receives: Drug: Sodium Hyaluronate Ophthalmic 0.4%
Group 2; Thealoz® DuoActive comparatorThealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Receives: Drug: Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)

  2. 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.

    Measured: 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 outcomes (4)

  1. 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.

    Measured: Days: 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)

  2. 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)

    Measured: 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)

  3. 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).

    Measured: 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)

  4. 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

    Measured: Day: 17 (± 1) (safety call)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2021
  2. Study start3 Sep 2022
  3. Primary completion22 Dec 2023
  4. Study completion22 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparative, controlled, parallel group, open, randomized multicenter study
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04704518
Sponsor's protocol ID
SOPH037-0120/IV
Acronym
PRO-037
Status last verified
Mar 2026
First submitted
7 Jan 2021
Last updated
7 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium Hyaluronate Ophthalmic 0.4% and Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15% in people with Photorefractive Keratectomy and Corneal De-epithelialization, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Corneal Re-epithelialization (Time) (time frame: Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04704518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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