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Phase IV comparative, controlled, parallel group, open, randomized multicenter study to evaluate the efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo. Primary outcome measure is the time of corneal re-epithelialization after PRK surgery. Intervention includes administration of one of the experimental products quater per die (QID) for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1; Lagricel® Ofteno PF | Experimental | Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. |
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| Group 2; Thealoz® Duo | Active Comparator | Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate Ophthalmic 0.4% | Drug | Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Re-epithelialization (Time) | Corneal re-epithelialization will be evaluated through direct observation and photographic recording after application of fluorescein stain. After instillation of a drop of topical anesthetic (tetracaine 0.5%) a fluorescein strip will be applied on the inferior cul de sac while the patient looks upward. Using a slit lamp with magnification of 6x and 16x photographs (at least 6 images for each magnification) will be obtained. | Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit) |
| Best Corrected Visual Acuity (BCVA) | (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: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Ocular Comfort Index | Ocular Comfort Index (OCI) Questionnaire will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome. | Days: 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
| Pain Perception |
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Inclusion Criteria:
Exclusion Criteria:
Having suffered any complications during and after PRK surgical procedure previous to inclusion in the study.
Use of mitomycin during PRK
Being subjected to PRK retreatment of previous history of any other kind of refractive surgery.
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.
Diagnosis of any of the following:
Previous history of drug addiction within the last 2 years previous 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.
Previous history of any medical affliction, acute or chronic (such as Diabetes Mellitus type I/II, autoimmune diseases or HIV), 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.
Use of medications (such as retinoic acid) that according to the investigator's criteria 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 |
|---|---|---|---|---|---|---|
| Aris Vision Institute de Guadalajara, S. C. | Guadalajara | Jalisco | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1; Lagricel® Ofteno PF | Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID. |
| FG001 | Group 2; Thealoz® Duo |
| 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 | Jan 26, 2022 |
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Comparative, controlled, parallel group, open, randomized multicenter study
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| Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15% | Drug | Topical ophthalmic administration of one drop of Thealoz® Duo QID. |
|
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Through a questionnaire, patients will be directly questioned about presence and severity of pain and associated symptoms. The scale will be as follows for severity: absent (0), very mild (1), mild (2), moderate (3) and severe (4) |
| Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
| Frequency of Pain Perception | Through a questionnaire, patients will be directly questioned about presence, severity and frequency of pain and associated symptoms. The scale will be as follows for frequency: never (0), almost never (1), 50% of the time (2), almost all the time (3) and all the time (4). | Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
| Unexpected Adverse Events (AEs) Related to the Investigational Product | The number of unexpected adverse events related to the investigational product that were recorded in each treatment group is described | Day: 17 (± 1) (safety call) |
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1; Lagricel® Ofteno PF | Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID. |
| BG001 | Group 2; Thealoz® Duo | Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Measure Analysis Population Description: Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Corneal epithelial defects | Count of Participants | Participants |
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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 | Changes in Corneal Re-epithelialization (Time) | Corneal re-epithelialization will be evaluated through direct observation and photographic recording after application of fluorescein stain. After instillation of a drop of topical anesthetic (tetracaine 0.5%) a fluorescein strip will be applied on the inferior cul de sac while the patient looks upward. Using a slit lamp with magnification of 6x and 16x photographs (at least 6 images for each magnification) will be obtained. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol, including adherence to treatment) | Posted | Mean | Standard Deviation | days | Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit) |
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| ||||||||||||||||||||||||||||
| Primary | Best Corrected Visual Acuity (BCVA) | (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 score | Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
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| Secondary | Changes in Ocular Comfort Index | Ocular Comfort Index (OCI) Questionnaire will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean 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) | Posted | Mean | Standard Deviation | score on a scale | Days: 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
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| Secondary | Pain Perception | Through a questionnaire, patients will be directly questioned about presence and severity of pain and associated symptoms. The scale will be as follows for severity: absent (0), very mild (1), mild (2), moderate (3) and severe (4) | The population evaluated for this outcome measure was the per-protocol population (PP, subjects who completed the study without significant deviations from the protocol). | Posted | Count of Participants | Participants | Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
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| Secondary | Frequency of Pain Perception | Through a questionnaire, patients will be directly questioned about presence, severity and frequency of pain and associated symptoms. The scale will be as follows for frequency: never (0), almost never (1), 50% of the time (2), almost all the time (3) and all the time (4). | The population evaluated for this outcome measure was the per-protocol population (PP, subjects who completed the study without significant deviations from the protocol). | Posted | Count of Participants | Participants | Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV) |
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| Secondary | Unexpected Adverse Events (AEs) Related to the Investigational Product | The number of unexpected adverse events related to the investigational product that were recorded in each treatment group is described | This result was described using the intention-to-treat (ITT) population. | Posted | Number | number of events | Day: 17 (± 1) (safety call) |
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From day 1 (basal visit) to the safety call on day 17 (+1)
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.
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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; Lagricel® Ofteno PF | Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID. | 0 | 48 | 0 | 48 | 39 | 48 |
| EG001 | Group 2; Thealoz® Duo | Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days. Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID. | 0 | 47 | 0 | 47 | 37 | 47 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased visual acuity | Eye disorders | Systematic Assessment |
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| Alteración corneal | Eye disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Corneal epithelial defect | Eye disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Eyelid edema | Eye disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Systematic Assessment |
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| Ocular hypertension | Eye disorders | Systematic Assessment |
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| Irritation in the instillation area | Eye disorders | Systematic Assessment |
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| Eye irritation | Eye disorders | Systematic Assessment |
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| Tearing | Eye disorders | Systematic Assessment |
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| Eye discomfort | Eye disorders | Systematic Assessment |
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| Dry eye | Eye disorders | Systematic Assessment |
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| Corneal opacity | Eye disorders | Systematic Assessment |
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| Ocular paresthesia | Eye disorders | Systematic Assessment |
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| Itchy eye | Eye disorders | Systematic Assessment |
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| Itching in the instillation area | Eye disorders | Systematic Assessment |
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| Abnormal sensation in the eye | Eye disorders | Systematic Assessment |
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| Foreign body sensation in the instillation area | Eye disorders | Systematic Assessment |
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| Foreign body sensation in the eyes | Eye disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Asthenopia | Eye disorders | Systematic Assessment |
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| Dyspepsia | Eye disorders | Systematic Assessment |
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| Conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Eye inflammation | Eye disorders | Systematic Assessment |
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| Punctate keratitis | Eye disorders | Systematic Assessment |
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| Pain in the upper abdomen | Gastrointestinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Gastrointestinal disorders | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-Rios M.D. | Laboratorios Sophia | :+52 (33) 3001 4200 | alejandra.sanchez@sophia.com.mx |
| Dec 19, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014199 | Trehalose |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |
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| Male |
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| Not Hispanic or Latin |
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| Unknown |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Mild pain |
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| Moderate mild |
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| Severe pain |
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| Mild pain |
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| Moderate mild |
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| Severe pain |
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| Mild pain |
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| Moderate mild |
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| Severe pain |
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| Mild pain |
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| Moderate mild |
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| Severe pain |
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| 50% of the time |
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| Almost all the time |
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| At all times |
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| 50% of the time |
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| Almost all the time |
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| At all times |
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| 50% of the time |
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| Almost all the time |
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| At all times |
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| 50% of the time |
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| Almost all the time |
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| At all times |
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