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Study design:
Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects of the Nanodrop® group, if there are less than 20% of unexpected Events (EA), related to the research product, recruitment is continued until the sample is completed for efficacy analysis
objectives Security: Evaluate the safety of the ophthalmic application of Nanodrop® by quantifying the incidence of unexpected Adverse Events (EA) related to the research product (PI).
Effectiveness: Demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance, in the efficacy of the treatment of patients with dry eye, by means of the Ocular Surface Disease Index (OSDI).
Hypothesis
Security:
H0 = Nanodrop® is safe in its ophthalmic application as it presents an incidence of unexpected adverse events related to the research drug, less than 20% of the population of Nanodrop® safety group.
H1 = Nanodrop® is not safe in its ophthalmic application, as it presents an incidence of unexpected adverse events related to the research drug, exceeding 20% of the population of Nanodrop® safety group.
Effectiveness:
H0 = Nanodrop® is lower than Systane® Balance by more than 5 points in the OSDI test score.
H1 = Nanodrop® is lower than Systane® Balance by 5 points or less in the OSDI test score.
Number of subjects: n = 126 evaluable subjects 63 evaluable subjects per group (both eyes).
Main inclusion criteria: Dry eye diagnosis
Duration of intervention treatment: 28 days Approximate duration of the subject in the study: 35 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanodrop® (PRO-176) | Experimental | - Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic. |
|
| Systane® Balance | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanodrop® | Drug | minimum to meet 1 drop 4 times a day, both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | will be evaluated at the end of the treatment (day 29, final visit) |
| Percentage of Unexpected Adverse Events (AE) Related to the Research Product | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent | during the 29 days of evaluation, including the safety call |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) | 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. |
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Inclusion Criteria:
OSDI ≥ 13 points plus one of the following:
Exclusion Criteria:
Allergic, viral or bacterial conjunctivitis. Anterior blepharitis. Demodex. Eye parasitic infections. Unresolved eye trauma. Healing diseases of the ocular surface. Corneal or conjunctival ulcers. Filamentous keratitis. Neurotrophic keratitis. Bullous keratopathy. Neoplastic diseases on the ocular surface or annexes. Diseases with fibrovascular proliferations on the conjunctival and / or corneal surface.
Diseases in the retina and / or posterior segment that require treatment or threaten the visual prognosis.
Glaucoma
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo Baiza Durán, MD | Laboratorios Sophia S.A de C.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catarata y Glaucoma de Occidente | Guadalajara | Jalisco | 44160 | Mexico | ||
| Clínica de Investigación en Reumatología y Obesidad S.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37077305 | Derived | Baiza-Duran LM, Munoz-Villegas P, Sanchez-Rios A, Olvera-Montano O. Efficacy and Safety of an Ophthalmic DMPC-Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial. J Ophthalmol. 2023 Apr 10;2023:1431473. doi: 10.1155/2023/1431473. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nanodrop® (PRO-176) | - Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic. Nanodrop®: minimum to meet 1 drop 4 times a day, both eyes |
| FG001 | Systane® Balance |
Systane Balance: minimum to meet 1 drop 4 times a day, both eyes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
| ID | Title | Description |
|---|---|---|
| BG000 | Nanodrop® (PRO-176) | - Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic. Nanodrop®: minimum to meet 1 drop 4 times a day, both eyes |
| BG001 | Systane® Balance |
| 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 |
| 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 | 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 PP population (subjects who finished the study without presenting any mayor deviations to protocol) | Posted | Mean | Standard Deviation | score on a scale | will be evaluated at the end of the treatment (day 29, final visit) |
|
Time frame will be evaluated from day 1 (basal visit) to the final visit day 28 (±1 days).
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 sponsor's monitor team, the pharmacovigilance specialist, and the medical specialist to verify adherence to procedures 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 | Nanodrop® (PRO-176) | - Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic. Nanodrop®: minimum to meet 1 drop 4 times a day, both eyes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning 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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 11, 2018 | Jun 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2019 | Jun 25, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019946 | Propylene Glycol |
| ID | Term |
|---|---|
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Phase I-II clinical trial, comparative, non-inferiority with active control, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects
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Masking will be done through the primary and secondary packaging.
They will be identified by means of identical tags. Which, in compliance with current and applicable regulations, must contain at least:
| Systane Balance | Drug | minimum to meet 1 drop 4 times a day, both eyes |
|
|
| will be evaluated at the end of the treatment (day 29, final visit) |
| Epithelial Defects (ED) Fluorescein Stain | The epithelial defects will be evaluated by fluorescein, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA).According to the CTO, grade 0 corresponds to the absence of dotted epithelial erosions (EEP); Grade 1 is defined as the presence of 1-5 EEP; Grade 2 corresponds to 6-30 EEP; and> 30 EEP will be classified as grade 3. Additionally a qualification point will be added if: 1) EEP is presented in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches are observed, including linear stains. A greater score is a worse outcome. | will be evaluated at the end of the treatment (day 29, final visit) |
| Epithelial Defects (ED) Green Lissamine | The epithelial defects will be evaluated by green lissamine, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA). In the CTO, grade 0 is defined as the presence of 0 to 9 lissamine green staining points in the interpalpebral bulbar conjunctiva (qualifying the temporal and nasal portion separately); grade 1 is defined by the presence of 10 to 32 points; grade 2 by 33 to 100; and grade 3 for> 100 points. Due to the difficulty of counting individual points in a moving eye, any area ≥ 4mm2 of confluent points is considered> 100 points. A higher score is a worse outcome. | will be evaluated at the end of the treatment (day 29, final visit) |
| Incidence of Expected Adverse Events | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent | will be evaluated at the end of the treatment (day 29, final visit) |
| Tear Breakup Time (TBUT) | brake up time of the tear film One of the first aspects of the tear film that changes when there is an alteration to the ocular surface is its stability. In general, if the corneal or conjunctival surface is damaged, it is unlikely that a stable tear film can be maintained. The most common method to evaluate tear film stability is the evaluation of TBUT with fluorescein. Once the fluorescein is instilled, with the cobalt blue filter the patient is asked not to blink after having blinked 1 to 2 times. The colored precorneal fluorescein layer will change to less fluorescent or non-fluorescent regions. The time that elapses from the last blink to the appearance of these regions is the TBUT. It will be reported in seconds. | will be evaluated at the end of the treatment (day 29, final visit) |
| Guadalajara |
| Jalisco |
| 44650 |
| Mexico |
| Jose Navarro Partida | Guadalajara | Jalisco | 45160 | Mexico |
| Health Pharma Professional Research S.A. de C.V. | Mexico City | Mexico City | 03100 | Mexico |
| Asociación para Evitar la Ceguera en México, I.A.P. | Mexico City | Mexico City | 04030 | Mexico |
| Centro Potosino de Investigación Médica SC | San Luis Potosí City | 78250 | Mexico |
Systane Balance: minimum to meet 1 drop 4 times a day, both eyes |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| Participants |
| Participants |
|
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Intraocular Pressure (IOP) | Mean | Standard Deviation | mmhg | Eyes |
|
|
| OG001 | Systane® Balance |
Systane Balance: minimum to meet 1 drop 4 times a day, both eyes |
|
|
| Primary | Percentage of Unexpected Adverse Events (AE) Related to the Research Product | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent | This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they adhered to the study protocol. | Posted | Number | percentage of unexpected related AE | during the 29 days of evaluation, including the safety call |
|
|
|
| Secondary | Visual Acuity (VA) | 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. | 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 | decimal score (Snellen Chart) | will be evaluated at the end of the treatment (day 29, final visit) |
|
|
|
| Secondary | Epithelial Defects (ED) Fluorescein Stain | The epithelial defects will be evaluated by fluorescein, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA).According to the CTO, grade 0 corresponds to the absence of dotted epithelial erosions (EEP); Grade 1 is defined as the presence of 1-5 EEP; Grade 2 corresponds to 6-30 EEP; and> 30 EEP will be classified as grade 3. Additionally a qualification point will be added if: 1) EEP is presented in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches are observed, including linear stains. A greater score 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) | Posted | Mean | Standard Deviation | score on a scale | will be evaluated at the end of the treatment (day 29, final visit) | Eyes | Eyes |
|
|
|
| Secondary | Epithelial Defects (ED) Green Lissamine | The epithelial defects will be evaluated by green lissamine, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA). In the CTO, grade 0 is defined as the presence of 0 to 9 lissamine green staining points in the interpalpebral bulbar conjunctiva (qualifying the temporal and nasal portion separately); grade 1 is defined by the presence of 10 to 32 points; grade 2 by 33 to 100; and grade 3 for> 100 points. Due to the difficulty of counting individual points in a moving eye, any area ≥ 4mm2 of confluent points is considered> 100 points. A higher score 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) | Posted | Mean | Standard Deviation | score on a scale | will be evaluated at the end of the treatment (day 29, final visit) | Eyes | Eyes |
|
|
|
| Secondary | Incidence of Expected Adverse Events | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent | This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they adhered to the study protocol. | Posted | Number | percentage of adverse events per group | will be evaluated at the end of the treatment (day 29, final visit) |
|
|
|
| Secondary | Tear Breakup Time (TBUT) | brake up time of the tear film One of the first aspects of the tear film that changes when there is an alteration to the ocular surface is its stability. In general, if the corneal or conjunctival surface is damaged, it is unlikely that a stable tear film can be maintained. The most common method to evaluate tear film stability is the evaluation of TBUT with fluorescein. Once the fluorescein is instilled, with the cobalt blue filter the patient is asked not to blink after having blinked 1 to 2 times. The colored precorneal fluorescein layer will change to less fluorescent or non-fluorescent regions. The time that elapses from the last blink to the appearance of these regions is the TBUT. It will be reported in seconds. | 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 | reported in seconds | will be evaluated at the end of the treatment (day 29, final visit) |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 54 |
| 63 |
| EG001 | Systane® Balance |
Systane Balance: minimum to meet 1 drop 4 times a day, both eyes | 0 | 63 | 1 | 63 | 47 | 63 |
| Irritation in the area of instillation | Eye disorders | Systematic Assessment |
|
| sensation of ocular pain | Eye disorders | Systematic Assessment |
|
| pruritus | Eye disorders | Systematic Assessment |
|
| blurred vision | Eye disorders | Systematic Assessment |
|
| ineffective drug | Product Issues | Systematic Assessment |
|
| conjunctival hyperemia | Eye disorders | Systematic Assessment |
|
| tearing | Eye disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| asthenopia | Eye disorders | Systematic Assessment |
|
| corneal lesion | Eye disorders | Systematic Assessment |
|
| conjunctivitis | Eye disorders | Systematic Assessment |
|
| epistaxis | Vascular disorders | Systematic Assessment |
|
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