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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04702776
Acronym
PRO-087
Enrollment
182
Registered
2021-01-11
Start date
2021-12-09
Completion date
2023-05-15
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Brief 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.

Interventions

DRUGSodium 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.

DRUGSodium hyaluronate 0.15%

Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.

DRUGSodium hyaluronate 0.4%

Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.

Sponsors

Laboratorios Sophia S.A de C.V.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

After signing the informed consent form (ICF), every subject will receive a coded patient number and will be assigned randomly to one of the investigation products.

Intervention model description

Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Ocular Surface Disease Index (OSDI)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.

Secondary

MeasureTime frameDescription
Noninvasive Keratograph Break-up Time (NIKBUT)Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).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.
Change of Conjunctival and Corneal Staining With Lissamine GreenDays: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).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.
Change of Conjunctival and Corneal Staining With FluoresceinDays: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).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.
Change in Conjunctival HyperemiaDays: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).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.
Incidence of Related Non Expected Adverse EventsDays: 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).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.
Change in Best Corrected Visual Acuity (BCVA)Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).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.
Change in Incidence of ChemosisDays: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).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.

Countries

Mexico

Participant flow

Pre-assignment details

The minimun sample size was not reached secondary to follow up loss and protocol deviations. Therefore, the efficacy analysis was performed in an exploratory manner and it was not possible to contrast the hypoteses.

Participants by arm

ArmCount
Arm 1; Humylub Ofteno® PF
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days. 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.
61
Arm 2; Hyabak®
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days. Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
61
Arm 3; Lagricel Ofteno® PF
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days. Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
60
Total182

Baseline characteristics

CharacteristicArm 1; Humylub Ofteno® PFArm 2; Hyabak®Arm 3; Lagricel Ofteno® PFTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
61 Participants61 Participants60 Participants182 Participants
Age, Continuous29.5 years
STANDARD_DEVIATION 11
31.7 years
STANDARD_DEVIATION 11.7
31.4 years
STANDARD_DEVIATION 10.2
30.9 years
STANDARD_DEVIATION 11
Conjunctival hyperemia24 Participants19 Participants16 Participants59 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
61 Participants61 Participants60 Participants182 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Mexico
61 participants61 participants60 participants182 participants
Sex: Female, Male
Female
33 Participants33 Participants36 Participants102 Participants
Sex: Female, Male
Male
28 Participants28 Participants24 Participants80 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 610 / 610 / 60
other
Total, other adverse events
40 / 6139 / 6143 / 60
serious
Total, serious adverse events
1 / 610 / 610 / 60

Outcome results

Primary

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.

Time frame: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Population: In total, 18 participants were discontinued from the study.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1; Humylub Ofteno® PFChange in Ocular Surface Disease Index (OSDI)First follow-up visit16.4 score on a scaleStandard Deviation 8.3
Arm 1; Humylub Ofteno® PFChange in Ocular Surface Disease Index (OSDI)Elegibility visit26.4 score on a scaleStandard Deviation 5.1
Arm 1; Humylub Ofteno® PFChange in Ocular Surface Disease Index (OSDI)Final visit11.2 score on a scaleStandard Deviation 9.4
Arm 2; Hyabak®Change in Ocular Surface Disease Index (OSDI)First follow-up visit14.0 score on a scaleStandard Deviation 10.4
Arm 2; Hyabak®Change in Ocular Surface Disease Index (OSDI)Elegibility visit26.3 score on a scaleStandard Deviation 5.8
Arm 2; Hyabak®Change in Ocular Surface Disease Index (OSDI)Final visit8.8 score on a scaleStandard Deviation 7.5
Arm 3; Lagricel Ofteno® PFChange in Ocular Surface Disease Index (OSDI)Elegibility visit26.6 score on a scaleStandard Deviation 4.9
Arm 3; Lagricel Ofteno® PFChange in Ocular Surface Disease Index (OSDI)Final visit10.7 score on a scaleStandard Deviation 9
Arm 3; Lagricel Ofteno® PFChange in Ocular Surface Disease Index (OSDI)First follow-up visit15.2 score on a scaleStandard Deviation 8.3
Secondary

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

Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1; Humylub Ofteno® PFChange in Best Corrected Visual Acuity (BCVA)Elegibility visit0.97 decimalStandard Deviation 0.18
Arm 1; Humylub Ofteno® PFChange in Best Corrected Visual Acuity (BCVA)First follow-up visit0.99 decimalStandard Deviation 0.17
Arm 1; Humylub Ofteno® PFChange in Best Corrected Visual Acuity (BCVA)Final visit0.99 decimalStandard Deviation 0.2
Arm 2; Hyabak®Change in Best Corrected Visual Acuity (BCVA)Elegibility visit0.95 decimalStandard Deviation 0.21
Arm 2; Hyabak®Change in Best Corrected Visual Acuity (BCVA)First follow-up visit0.98 decimalStandard Deviation 0.26
Arm 2; Hyabak®Change in Best Corrected Visual Acuity (BCVA)Final visit0.96 decimalStandard Deviation 0.18
Arm 3; Lagricel Ofteno® PFChange in Best Corrected Visual Acuity (BCVA)Final visit0.96 decimalStandard Deviation 0.22
Arm 3; Lagricel Ofteno® PFChange in Best Corrected Visual Acuity (BCVA)First follow-up visit0.96 decimalStandard Deviation 0.22
Arm 3; Lagricel Ofteno® PFChange in Best Corrected Visual Acuity (BCVA)Elegibility visit0.94 decimalStandard Deviation 0.2
Secondary

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.

Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Population: In total, 18 participants were discontinued from the study.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFinal visitMild3 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitSevere0 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaElegibility visitNormal21 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFinal visitModerate0 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitModerate0 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitVery Mild17 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFinal visitSevere0 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaElegibility visitMild9 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitNormal23 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFinal visitNormal32 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaElegibility visitSevere0 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitMild6 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaFinal visitVery Mild11 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaElegibility visitModerate2 Participants
Arm 1; Humylub Ofteno® PFChange in Conjunctival HyperemiaElegibility visitVery Mild14 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaElegibility visitVery Mild17 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFirst follow-up visitMild5 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFirst follow-up visitModerate0 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFirst follow-up visitSevere0 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFinal visitNormal33 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFinal visitVery Mild14 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFinal visitMild2 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFinal visitModerate0 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFinal visitSevere0 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFirst follow-up visitNormal22 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaFirst follow-up visitVery Mild22 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaElegibility visitNormal15 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaElegibility visitMild15 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaElegibility visitModerate2 Participants
Arm 2; Hyabak®Change in Conjunctival HyperemiaElegibility visitSevere0 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFinal visitMild0 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaElegibility visitModerate3 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaElegibility visitNormal14 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFinal visitVery Mild13 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFinal visitNormal27 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaElegibility visitVery Mild12 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitSevere0 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitMild4 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaElegibility visitMild11 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFinal visitSevere0 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitModerate0 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitNormal22 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFinal visitModerate0 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaElegibility visitSevere0 Participants
Arm 3; Lagricel Ofteno® PFChange in Conjunctival HyperemiaFirst follow-up visitVery Mild14 Participants
Secondary

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.

Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1; Humylub Ofteno® PFChange in Incidence of ChemosisElegibility visit0 Participants
Arm 1; Humylub Ofteno® PFChange in Incidence of ChemosisFirst follow-up visit0 Participants
Arm 1; Humylub Ofteno® PFChange in Incidence of ChemosisFinal visit0 Participants
Arm 2; Hyabak®Change in Incidence of ChemosisFirst follow-up visit0 Participants
Arm 2; Hyabak®Change in Incidence of ChemosisElegibility visit0 Participants
Arm 2; Hyabak®Change in Incidence of ChemosisFinal visit0 Participants
Arm 3; Lagricel Ofteno® PFChange in Incidence of ChemosisFirst follow-up visit0 Participants
Arm 3; Lagricel Ofteno® PFChange in Incidence of ChemosisFinal visit0 Participants
Arm 3; Lagricel Ofteno® PFChange in Incidence of ChemosisElegibility visit0 Participants
Secondary

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.

Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Population: In total, 18 participants were discontinued from the study.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visit036 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visitI19 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visitIII1 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visitII0 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visit019 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visit031 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visitI10 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visitIII0 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitI12 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visitII7 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitIII0 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitII3 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinElegibility visitII2 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitIII0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFinal visit034 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFinal visitI15 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinElegibility visitI27 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFinal visitII0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitII4 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFinal visitIII0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinElegibility visitIII0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visit023 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinElegibility visit020 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitI22 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visitIII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitIII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visit016 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visitI20 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visitII4 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinElegibility visitIII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visit025 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitI14 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visit024 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visitI14 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFinal visitII2 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With FluoresceinFirst follow-up visitII1 Participants
Secondary

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.

Time frame: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Population: In total, 18 participants were discontinued from the study.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visit025 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitII3 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visit033 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitI16 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitI21 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitIV1 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitII4 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitII1 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitIII0 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitIII2 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitIV0 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visit020 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitIV0 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitIII0 Participants
Arm 1; Humylub Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitI12 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFinal visitI15 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenEligibility visit023 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitI22 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitII4 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitIII0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitIV0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visit028 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitI19 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitII1 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitIII1 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitIV0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFinal visit032 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFinal visitII2 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFinal visitIII0 Participants
Arm 2; Hyabak®Change of Conjunctival and Corneal Staining With Lissamine GreenFinal visitIV0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visit025 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitIII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visit023 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitIV0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitIII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitI17 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visit016 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitII3 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenEligibility visitI24 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitIII0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitI12 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFinal visitIV0 Participants
Arm 3; Lagricel Ofteno® PFChange of Conjunctival and Corneal Staining With Lissamine GreenFirst follow-up visitIV0 Participants
Secondary

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.

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).

ArmMeasureValue (NUMBER)
Arm 1; Humylub Ofteno® PFIncidence of Related Non Expected Adverse Events5 adverse events
Arm 2; Hyabak®Incidence of Related Non Expected Adverse Events5 adverse events
Arm 3; Lagricel Ofteno® PFIncidence of Related Non Expected Adverse Events10 adverse events
Secondary

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.

Time frame: Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).

Population: In total, 18 participants were discontinued from the study.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1; Humylub Ofteno® PFNoninvasive Keratograph Break-up Time (NIKBUT)First follow-up visit7.3 secondsStandard Deviation 4.8
Arm 1; Humylub Ofteno® PFNoninvasive Keratograph Break-up Time (NIKBUT)Baseline visit6.8 secondsStandard Deviation 3.9
Arm 1; Humylub Ofteno® PFNoninvasive Keratograph Break-up Time (NIKBUT)Final visit8.7 secondsStandard Deviation 5.3
Arm 2; Hyabak®Noninvasive Keratograph Break-up Time (NIKBUT)First follow-up visit6.9 secondsStandard Deviation 4.8
Arm 2; Hyabak®Noninvasive Keratograph Break-up Time (NIKBUT)Baseline visit5.2 secondsStandard Deviation 3
Arm 2; Hyabak®Noninvasive Keratograph Break-up Time (NIKBUT)Final visit7.8 secondsStandard Deviation 4.9
Arm 3; Lagricel Ofteno® PFNoninvasive Keratograph Break-up Time (NIKBUT)Baseline visit7.1 secondsStandard Deviation 4.3
Arm 3; Lagricel Ofteno® PFNoninvasive Keratograph Break-up Time (NIKBUT)Final visit7.1 secondsStandard Deviation 3.9
Arm 3; Lagricel Ofteno® PFNoninvasive Keratograph Break-up Time (NIKBUT)First follow-up visit7.7 secondsStandard Deviation 4.9

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026