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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Group 3 | Experimental | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID) | Drug | Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to Day 33 (+ 1) (safety call). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). |
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Inclusion Criteria:
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:
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 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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Jalisciense del Metabolismo, S.C. | Guadalajara | Jalisco | 44670 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | 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. Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID. |
| FG001 | Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Feb 20, 2020 |
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Comparative, controlled, multicenter, open, randomized clinical study.
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| Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID) | Drug | Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID. |
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| Sodium Hyaluronate Ophthalmic 0.4% Six times per day | Drug | Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day. |
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| 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). | 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). | 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). | 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. | 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. | 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. | BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit). |
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop four time a days (QID) in both eyes (OU) during 30 days. Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID. |
| FG002 | Group 3 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop six times per day in both eyes (OU) during 30 days. Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID. |
| BG001 | Group 2 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID. |
| BG002 | Group 3 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Brake up time of the tear film | Mean | Standard Deviation | seconds |
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| 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 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,). |
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| Primary | 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. | This outcome measure considered the Safety Population (SP), all participants who were randomized and exposed to treatment, regardless of whether they finished the study. | Posted | Number | adverse events | Up to Day 33 (+ 1) (safety call). | Eyes | Eyes |
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| Secondary | 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. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable. | Posted | Mean | Standard Deviation | seconds | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | Eyes (right) | Eyes (right) |
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| Secondary | 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). | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable. | Posted | Number | Eyes (right) | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | Eyes (right) | Eyes (right) |
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| Secondary | 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). | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable. | Posted | Number | Eyes (right) | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | Eyes (right) | Eyes (right) |
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| Secondary | 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). | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable. | Posted | Number | Eyes (right) | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | Eyes (right) | Eyes (right) |
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| Secondary | 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. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable. | Posted | Number | Eyes (right) | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | Eyes (right) | Eyes (right) |
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| 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 (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. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable. | Posted | Mean | Standard Deviation | decimal score | Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1). | Eyes (right) | Eyes (right) |
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| Secondary | 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. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Only the values from the right eye were evaluated for this variable. | Posted | Mean | Standard Deviation | mmHg | BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit). | Eyes (right) | Eyes (right) |
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From day 1 (basal visit) to the safety call on day 33 (±1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic case report form (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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) BID in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% BID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID. | 0 | 47 | 1 | 47 | 22 | 47 |
| EG001 | Group 2 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) QID in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% QID: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID. | 0 | 47 | 0 | 47 | 22 | 47 |
| EG002 | Group 3 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day. | 0 | 47 | 0 | 47 | 22 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| reaction to immunization | Immune system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation in the area of instillation | Eye disorders | Systematic Assessment |
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| Pruritus | Eye disorders | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Foreign body sensation in the eye | Eye disorders | Systematic Assessment |
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| Asthenopia | Eye disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Stye eye (hordeolum) | Eye disorders | Systematic Assessment |
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| Tearing | Eye disorders | Systematic Assessment |
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| conjunctivitis | Eye disorders | Systematic Assessment |
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| photophobia | Eye disorders | Systematic Assessment |
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| abnormal sensation in the eye | Eye disorders | Systematic Assessment |
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| dysmenorrhea | Endocrine disorders | Systematic Assessment |
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| diplopia | Eye disorders | Systematic Assessment |
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| presence of product residue | Product Issues | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Pain in area of administration | Eye disorders | Systematic Assessment |
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| Ocular Pain | Eye disorders | Systematic Assessment |
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| Flu-like illness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | Systematic Assessment |
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| Hypoesthesia | Nervous system disorders | Systematic Assessment |
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| Ocular irritation | Eye disorders | Systematic Assessment |
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| Eyelid irritation | Eye disorders | Systematic Assessment |
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| Sticky Skin | General disorders | Systematic Assessment |
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| Abormal ocular sensation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-Ríos M.D. | Laboratorios Sophia | :+52 (33) 3001 4200 | alejandra.sanchez@sophia.com.mx |
| Dec 19, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
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Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day. |
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Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day. |
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Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
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| OG002 | Group 3 | Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days. Sodium Hyaluronate Ophthalmic 0.4% Six times per day: Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day. |
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