Dry EyePhase 4PRO-087NCT04702776
Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.
A Phase 4 study testing Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%, Sodium hyaluronate 0.15% and Sodium hyaluronate 0.4% in people with Dry Eye, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%, Sodium hyaluronate 0.15% and Sodium hyaluronate 0.4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteMexico
- Study dates
- 9 Dec 2021to 15 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- More than 5 dots of corneal staining
- More than 9 dots of conjunctival staining
- Tear break-up time < 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 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
Guadalajara, Jalisco, 44190
About this study
Official title: 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.
- Conditions
- Dry Eye
- Being tested
- Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%, Sodium hyaluronate 0.15%, Sodium hyaluronate 0.4%
- 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 0.1%/chondroitin sulfate 0.18%Drug
Also called Humylub Ofteno® PF, PRO-087
Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
Sodium hyaluronate 0.15%Drug
Also called Hyabak® PF
Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
Sodium hyaluronate 0.4%Drug
Also called Lagricel Ofteno® PF, PRO-037
Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1; Humylub Ofteno® PF | Experimental | Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days. Receives: Drug: Sodium hyaluronate 0.1%/chondroitin sulfate 0.18% |
| Arm 2; Hyabak® | Active comparator | Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days. Receives: Drug: Sodium hyaluronate 0.15% |
| Arm 3; Lagricel Ofteno® PF | Active comparator | Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days. Receives: Drug: Sodium hyaluronate 0.4% |
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 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.
Measured: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
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.
Measured: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start9 Dec 2021
- Primary completion15 May 2023
- Study completion15 May 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702776
- Sponsor's protocol ID
- SOPH087-0120/IV
- Acronym
- PRO-087
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2021
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39233999
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04702776
- Acronym / sponsor ID
- PRO-087 / SOPH087-0120/IV
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 13 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study
| Arm | Type | Receives |
|---|---|---|
| Arm 1; Humylub Ofteno® PF | Experimental | Drug: Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days. |
| Arm 2; Hyabak® | Active comparator | Drug: Sodium hyaluronate 0.15%Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days. |
| Arm 3; Lagricel Ofteno® PF | Active comparator | Drug: Sodium hyaluronate 0.4%Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 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)
- 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:
Key exclusion criteria (25 listed)
- - 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:
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 0.1%/chondroitin sulfate 0.18%Also: Humylub Ofteno® PF, PRO-087Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days. | Drug | Arm 1; Humylub Ofteno® PF |
| Sodium hyaluronate 0.15%Also: Hyabak® PFApplication of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days. | Drug | Arm 2; Hyabak® |
| Sodium hyaluronate 0.4%Also: Lagricel Ofteno® PF, PRO-037Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days. | Drug | Arm 3; Lagricel Ofteno® PF |
Primary outcome
Change in Ocular Surface Disease Index (OSDI)
Time frame: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
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.
7 secondary outcomes
Noninvasive Keratograph Break-up Time (NIKBUT)
Time frame: 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
Time frame: 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
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change in Conjunctival Hyperemia
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Incidence of Related Non Expected Adverse Events
Time frame: 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 Best Corrected Visual Acuity (BCVA)
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Change in Incidence of Chemosis
Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39233999Munoz-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.
- 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?
A Phase 4 study testing Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%, Sodium hyaluronate 0.15% and Sodium hyaluronate 0.4% in people with Dry Eye, 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 25 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 20 Feb 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 13 Jan 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: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).). 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 NCT04702776, which also lists 1 linked publication.
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 20 Feb 2026.