Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1; Humylub Ofteno® PF | Experimental | Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days. |
|
| Arm 2; Hyabak® | Active Comparator | Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days. |
|
| Arm 3; Lagricel Ofteno® PF | Active Comparator | Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium hyaluronate 0.1%/chondroitin sulfate 0.18% | Drug | Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad ClÃnica de Bioequivalencia, S. de R.L. de C.V. | Guadalajara | Jalisco | 44190 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39233999 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2020 |
Not provided
Phase IV, non inferiority, controlled, open, comparative, multicenter clinical study
Not provided
Not provided
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.
|
| Sodium hyaluronate 0.15% | Drug | Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days. |
|
|
| Sodium hyaluronate 0.4% | Drug | Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
| 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. |
| FG002 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Measure Analysis Population Description: Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Conjunctival hyperemia | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | In total, 18 participants were discontinued from the study. | Posted | Mean | Standard Deviation | score on a scale | Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
|
|
| ||||||||||||||||||||||||||||||||
| 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. | In total, 18 participants were discontinued from the study. | Posted | Mean | Standard Deviation | seconds | Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
| ||||||||||||||||||||||||||||||||||
| 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. | In total, 18 participants were discontinued from the study. | Posted | Count of Participants | Participants | Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
| |||||||||||||||||||||||||||||||||||
| 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. | In total, 18 participants were discontinued from the study. | Posted | Count of Participants | Participants | Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
| |||||||||||||||||||||||||||||||||||
| 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. | In total, 18 participants were discontinued from the study. | Posted | Count of Participants | Participants | Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
| |||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | adverse events | 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). |
| ||||||||||||||||||||||||||||||||||||
| 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 20/20. 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. | 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. | Posted | Mean | Standard Deviation | decimal | Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit). |
|
Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 61 | 1 | 61 | 40 | 61 |
| EG001 | 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. | 0 | 61 | 0 | 61 | 39 | 61 |
| EG002 | 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. | 0 | 60 | 0 | 60 | 43 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsive Crisis | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular burning | Eye disorders | Systematic Assessment |
| ||
| Pruritus | Eye disorders | Systematic Assessment |
| ||
| Ocular hyperemia | Eye disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Foreign body sensation in the eye | Eye disorders | Systematic Assessment |
| ||
| Eyestrain | Eye disorders | Systematic Assessment |
| ||
| Tearing | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez RÃos | Laboratorios Sophia | + 52 33 3001 4200 | 1190 | alejandra.sanchez@sophia.com.mx |
| Dec 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
| Final visit |
|
|
|
| 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. |
|
|
| 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. |
|
|
|
|
|
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| II |
|
| III |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|