Dry EyePhase 2PRO-037NCT04704531

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

A Phase 2 study testing Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID), Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID) and Sodium Hyaluronate Ophthalmic 0.4% Six times per day in people with Dry Eye, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID), Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID) and Sodium Hyaluronate Ophthalmic 0.4% Six times per day
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 1 siteMexico
Study dates: 3 Jan 2022to 8 Jun 2022
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 9Show fewer

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

Who cannot join

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

Show all 24Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

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

Other trials in Mexico

About this study

Official title: 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).

Conditions: Dry Eye
Being tested: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID), Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID), Sodium Hyaluronate Ophthalmic 0.4% Six times per day
Medical subject headings: Dry Eye Syndromes

What participants receive

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

Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)Drug
Also called PRO-037, Lagricel® Ofteno
Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)Drug
Also called PRO-037, Lagricel® Ofteno
Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
Sodium Hyaluronate Ophthalmic 0.4% Six times per dayDrug
Also called PRO-037, Lagricel® Ofteno
Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.

Study groups in NCT04704531
Study group	Role	What they receive
Group 1	Experimental	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. Receives: Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)
Group 2	Experimental	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. Receives: Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)
Group 3	Experimental	Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days. Receives: Drug: Sodium Hyaluronate Ophthalmic 0.4% Six times per day

What is being measured

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

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.
Measured: 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.
Measured: Up to Day 33 (+ 1) (safety call).

Secondary outcomes (7)

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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit).

Timeline

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

3 Jan 20228 Jun 2022

First posted11 Jan 2021
Study start3 Jan 2022
Primary completion8 Jun 2022
Study completion8 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Comparative, controlled, multicenter, open, randomized clinical study.
Masking: None (open label)
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04704531
Sponsor's protocol ID: SOPH037-1219/II
Acronym: PRO-037
Status last verified: Feb 2026
First submitted: 7 Jan 2021
Last updated: 3 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04704531
Acronym / sponsor ID: PRO-037 / SOPH037-1219/II
Conditions: Dry Eye
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
Study start: 3 Jan 2022 (actual)
Primary completion: 8 Jun 2022 (actual)
Study completion: 8 Jun 2022 (actual)
First posted: 11 Jan 2021 (actual)
Results: Posted 3 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Comparative, controlled, multicenter, open, randomized clinical study.

Arm	Type	Receives
Group 1	Experimental	Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)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.
Group 2	Experimental	Drug: Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)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.
Group 3	Experimental	Drug: Sodium Hyaluronate Ophthalmic 0.4% Six times per dayApplication of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:

Key exclusion criteria (24 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID)Also: PRO-037, Lagricel® OftenoTopical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.	Drug	Group 1
Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID)Also: PRO-037, Lagricel® OftenoTopical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.	Drug	Group 2
Sodium Hyaluronate Ophthalmic 0.4% Six times per dayAlso: PRO-037, Lagricel® OftenoTopical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.	Drug	Group 3

Primary outcome

Change in Ocular Surface Disease Index (OSDI)
Time frame: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).
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.
Incidence of Adverse Events (AE)
Time frame: Up to Day 33 (+ 1) (safety call).
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.

7 secondary outcomes

Change in Tear Break-up Time (BUT)
Time frame: 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
Time frame: 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
Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Change in Conjunctival Hyperemia
Time frame: Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).
Incidence of Chemosis
Time frame: 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)
Time frame: 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)
Time frame: BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit).

Results and safety

Results posted to the registry on 3 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	47	45
Group 2	47	45
Group 3	47	46

Primary outcome: Change in Ocular Surface Disease Index (OSDI)

Time frame: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).. Mean (Standard Deviation). Unit: score on a scale

Measure	Group 1 n = 45	Group 2 n = 45	Group 3 n = 46
BV	25.8 (4.9)	25.8 (4.7)	24.8 (5.3)
FV	12.8 (6.0)	12.2 (5.8)	11.9 (6.9)

Population analysed: The evaluated population for this outcome measure was the population per protrocol (PP) (subjects who finished the study without presenting any mayor deviations to protocol)

Primary outcome: Incidence of Adverse Events (AE)

Time frame: Up to Day 33 (+ 1) (safety call).. Number. Unit: adverse events

Measure	Group 1 n = 47	Group 2 n = 47	Group 3 n = 47
Related and unexpected AE	24	17	22
Related and expected AE	11	9	7
Non-related AE	21	15	16

Population analysed: This outcome measure considered the Safety Population (SP), all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day 1 (basal visit) to the safety call on day 33 (±1 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	1 of 47 (2.1%)	22 of 47 (46.8%)	0 of 47
Group 2	0 of 47 (0%)	22 of 47 (46.8%)	0 of 47
Group 3	0 of 47 (0%)	22 of 47 (46.8%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 24 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 3 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 Mar 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?

Change in Ocular Surface Disease Index (OSDI) (time frame: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).). 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 NCT04704531.

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 3 Mar 2026.