Trial Outcomes & Findings for Clinical Trial to Compare the Safety and Efficacy of Nanodrop® (NCT NCT04111965)

NCT ID: NCT04111965

Last Updated: 2025-07-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

126 participants

Primary outcome timeframe

will be evaluated at the end of the treatment (day 29, final visit)

Results posted on

2025-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	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	Systane® Balance * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Overall Study STARTED	63	63
Overall Study COMPLETED	56	59
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nanodrop® (PRO-176) n=126 Eyes \- 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	Systane® Balance n=126 Eyes * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes	Total n=252 Eyes Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=63 Participants	0 Participants n=63 Participants	0 Participants n=126 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=63 Participants	57 Participants n=63 Participants	110 Participants n=126 Participants
Age, Categorical >=65 years	10 Participants n=63 Participants	6 Participants n=63 Participants	16 Participants n=126 Participants
Age, Continuous	47.8 years STANDARD_DEVIATION 17.4 • n=63 Participants	44.6 years STANDARD_DEVIATION 15.4 • n=63 Participants	46.18 years STANDARD_DEVIATION 16.45 • n=126 Participants
Sex: Female, Male Female	47 Participants n=63 Participants	40 Participants n=63 Participants	87 Participants n=126 Participants
Sex: Female, Male Male	16 Participants n=63 Participants	23 Participants n=63 Participants	39 Participants n=126 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Mexico	63 participants n=63 Participants	63 participants n=63 Participants	126 participants n=126 Participants
Intraocular Pressure (IOP)	13.8 mmhg STANDARD_DEVIATION 3.1 • n=126 Eyes	12.7 mmhg STANDARD_DEVIATION 2.5 • n=126 Eyes	13.20 mmhg STANDARD_DEVIATION 3.41 • n=252 Eyes

PRIMARY outcome

Timeframe: will be evaluated at the end of the treatment (day 29, final visit)

Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol)

Outcome measures

Outcome measures
Measure	Nanodrop® (PRO-176) n=54 Participants \- 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	Systane® Balance n=59 Participants * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Ocular Surface Disease Index (OSDI)	48.9 score on a scale Standard Deviation 19.2	50.3 score on a scale Standard Deviation 18.3

PRIMARY outcome

Timeframe: during the 29 days of evaluation, including the safety call

Population: 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.

the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent

Outcome measures

Outcome measures
Measure	Nanodrop® (PRO-176) n=63 Participants \- 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	Systane® Balance n=63 Participants * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Percentage of Unexpected Adverse Events (AE) Related to the Research Product	23.0 percentage of unexpected related AE	17.5 percentage of unexpected related AE

SECONDARY outcome

Timeframe: will be evaluated at the end of the treatment (day 29, final visit)

Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol)

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.

Outcome measures

Outcome measures
Measure	Nanodrop® (PRO-176) n=54 Participants \- 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	Systane® Balance n=59 Participants * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Visual Acuity (VA)	0.89 decimal score (Snellen Chart) Standard Deviation 0.18	0.90 decimal score (Snellen Chart) Standard Deviation 0.19

SECONDARY outcome

Timeframe: will be evaluated at the end of the treatment (day 29, final visit)

Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol)

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.

Outcome measures

Outcome measures
Measure	Nanodrop® (PRO-176) n=108 Eyes \- 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	Systane® Balance n=118 Eyes * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Epithelial Defects (ED) Fluorescein Stain	0.91 score on a scale Standard Deviation 0.92	0.93 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: will be evaluated at the end of the treatment (day 29, final visit)

Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol)

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.

Outcome measures

Outcome measures
Measure	Nanodrop® (PRO-176) n=108 Eyes \- 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	Systane® Balance n=118 Eyes * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Epithelial Defects (ED) Green Lissamine	0.83 score on a scale Standard Deviation 0.69	0.85 score on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: will be evaluated at the end of the treatment (day 29, final visit)

the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent

Outcome measures

Outcome measures
Measure	Nanodrop® (PRO-176) n=63 Participants \- 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	Systane® Balance n=63 Participants * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Incidence of Expected Adverse Events	77 percentage of adverse events per group	82.5 percentage of adverse events per group

SECONDARY outcome

Timeframe: will be evaluated at the end of the treatment (day 29, final visit)

Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol)

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.

Outcome measures

Outcome measures
Measure	Nanodrop® (PRO-176) n=54 Participants \- 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	Systane® Balance n=59 Participants * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Tear Breakup Time (TBUT)	2.28 reported in seconds Standard Deviation 2.9	2.02 reported in seconds Standard Deviation 2.9

Adverse Events

Nanodrop® (PRO-176)

Serious events: 0 serious events

Other events: 54 other events

Deaths: 0 deaths

Systane® Balance

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nanodrop® (PRO-176) n=63 participants at risk \- 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	Systane® Balance n=63 participants at risk * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Respiratory, thoracic and mediastinal disorders COVID-19	0.00% 0/63 • 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.	1.6% 1/63 • 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.

Other adverse events

Other adverse events
Measure	Nanodrop® (PRO-176) n=63 participants at risk \- 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	Systane® Balance n=63 participants at risk * Systane® Balance. 0.6% propylene glycol. Ophthalmic emulsion Alcon Laboratories, Inc. * Route of administration: Ophthalmic. Systane Balance: minimum to meet 1 drop 4 times a day, both eyes
Eye disorders Burning sensation	58.7% 37/63 • 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.	36.5% 23/63 • 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.
Eye disorders Irritation in the area of instillation	7.9% 5/63 • 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.	4.8% 3/63 • 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.
Eye disorders sensation of ocular pain	4.8% 3/63 • 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.	6.3% 4/63 • 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.
Eye disorders pruritus	17.5% 11/63 • 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.	20.6% 13/63 • 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.
Eye disorders blurred vision	6.3% 4/63 • 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.	17.5% 11/63 • 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.
Product Issues ineffective drug	20.6% 13/63 • 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.	25.4% 16/63 • 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.
Eye disorders conjunctival hyperemia	12.7% 8/63 • 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.	12.7% 8/63 • 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.
Eye disorders tearing	1.6% 1/63 • 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.	7.9% 5/63 • 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.
Nervous system disorders headache	11.1% 7/63 • 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.	1.6% 1/63 • 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.
Eye disorders asthenopia	3.2% 2/63 • 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.	3.2% 2/63 • 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.
Eye disorders corneal lesion	1.6% 1/63 • 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.	0.00% 0/63 • 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.
Eye disorders conjunctivitis	6.3% 4/63 • 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.	3.2% 2/63 • 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.
Vascular disorders epistaxis	1.6% 1/63 • 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.	0.00% 0/63 • 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.

Additional Information

Alejandra Sanchez-Ríos M.D.

Laboratorios Sophia

Phone: :+52 (33) 3001 4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place