Trial Outcomes & Findings for Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects (NCT NCT03519516)
NCT ID: NCT03519516
Last Updated: 2019-10-25
Results Overview
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
during the 12 days of evaluation, including the safety call (day 12).
Results posted on
2019-10-25
Participant Flow
Participant milestones
| Measure |
PRO-174
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PRO-174
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
Baseline characteristics by cohort
| Measure |
PRO-174
n=15 Participants
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=15 Participants
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.67 years
STANDARD_DEVIATION 4.15 • n=5 Participants
|
28.93 years
STANDARD_DEVIATION 9.38 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during the 12 days of evaluation, including the safety call (day 12).Population: the analysis of the population was by protocol
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
Outcome measures
| Measure |
PRO-174
n=15 Participants
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=14 Participants
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Number of Adverse Events (EAS)
|
11 adverse events
|
10 adverse events
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: the analysis of the study population was by protocol
primary tolerability variable Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Outcome measures
| Measure |
PRO-174
n=15 Participants
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Ocular Burning (OB)
Normal
|
86.7 percentage of participants
|
57.1 percentage of participants
|
|
Ocular Burning (OB)
Very mild
|
6.7 percentage of participants
|
14.3 percentage of participants
|
|
Ocular Burning (OB)
mild
|
6.7 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: The study population was analyzed by protocol
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Intraocular Pressure (IOP)
|
12.53 mmHg
Standard Deviation 1.0
|
12.68 mmHg
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: The study population was analyzed by protocol
breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Breakup Time (BUT)
|
15.27 seconds
Standard Deviation 2.7
|
15.79 seconds
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: The study population was analyzed by protocol
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Number of Eyes With Epithelial Defects (ED) by Grade
Green lissamine grade 1
|
2 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects (ED) by Grade
Green lissamine grade 0
|
28 eyes
|
28 eyes
|
|
Number of Eyes With Epithelial Defects (ED) by Grade
luorescein grade 1
|
3 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects (ED) by Grade
fluorescein grade 0
|
27 eyes
|
28 eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: The study population was analyzed by protocol
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
normal
|
96.7 percentage of eyes
|
92.9 percentage of eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
very mild
|
3.3 percentage of eyes
|
0 percentage of eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Mild
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
moderate
|
0 percentage of eyes
|
7.1 percentage of eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
severo
|
0 percentage of eyes
|
0 percentage of eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: The study population was analyzed by protocol
Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Absent
|
30 eyes
|
28 eyes
|
|
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Very mild
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Mild
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Moderate
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Severe
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: The study population was analyzed by protocol grade 1
Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Number of Eyes With Ocular Pruritus (P) by Grade
Absent
|
24 number of eyes with Ocular pruritus
|
24 number of eyes with Ocular pruritus
|
|
Number of Eyes With Ocular Pruritus (P) by Grade
Very mild
|
4 number of eyes with Ocular pruritus
|
2 number of eyes with Ocular pruritus
|
|
Number of Eyes With Ocular Pruritus (P) by Grade
Mild
|
2 number of eyes with Ocular pruritus
|
2 number of eyes with Ocular pruritus
|
|
Number of Eyes With Ocular Pruritus (P) by Grade
Moderate
|
0 number of eyes with Ocular pruritus
|
0 number of eyes with Ocular pruritus
|
|
Number of Eyes With Ocular Pruritus (P) by Grade
Severe
|
0 number of eyes with Ocular pruritus
|
0 number of eyes with Ocular pruritus
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)Population: the statistical analysis of the sample was performed by protocol
The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Number of Eyes of Chemosis
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment at the final visit (day 7)The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and higher scores indicate worse visual acuity. Snellen Scale: 20/200, 20/100, 20/70, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10 only the denominator of the fraction of each case is reported and averaged per group.
Outcome measures
| Measure |
PRO-174
n=30 eyes
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=28 eyes
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Visual Capacity
|
20.6 units on a scale (snellen)
Standard Deviation 2.17
|
20 units on a scale (snellen)
Standard Deviation 0
|
Adverse Events
PRO-174
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Sophixín Ofteno®
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-174
n=15 participants at risk
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
PRO-174: Pharmaceutical form: ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
Sophixín Ofteno®
n=15 participants at risk
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%
* Pharmaceutical form: Ophthalmic solution
* Prepared by: Laboratorios Sophia, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: sterile multi-dose bottle
|
|---|---|---|
|
Eye disorders
ocular burning
|
33.3%
5/15 • Number of events 5 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
46.7%
7/15 • Number of events 7 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
|
Eye disorders
itching in the eye
|
20.0%
3/15 • Number of events 3 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
6.7%
1/15 • Number of events 1 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
0.00%
0/15 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
6.7%
1/15 • Number of events 1 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
|
Eye disorders
conjunctival hyperemia
|
6.7%
1/15 • Number of events 1 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
0.00%
0/15 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
|
Eye disorders
tearing
|
0.00%
0/15 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
6.7%
1/15 • Number of events 1 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
|
Musculoskeletal and connective tissue disorders
skin rash
|
13.3%
2/15 • Number of events 2 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
0.00%
0/15 • the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
|
Additional Information
Ricardo Alonso Llamas Velázquez (clinical safety pharmacologist)
Laboratorios Sophia
Phone: +52 (33) 3001 4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee only the sponsor has the decision to disseminate or publish the information obtained from the investigation and the PIs involved must submit a formal request to the sponsor if they are willing to disseminate or publish such information, they may only publish them if they have the written authorization of the sponsor (Laboratoios Sophia S.A. de C.V.).
- Publication restrictions are in place
Restriction type: OTHER