Trial Outcomes & Findings for Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%. (NCT NCT03696342)
NCT ID: NCT03696342
Last Updated: 2021-08-24
Results Overview
The ocular secretion will be classified as 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The number will be reported according to the rating granted at final visit.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
will be evaluated at the end of the treatment (day 8, final visit)
Results posted on
2021-08-24
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
PRO-157
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
23 23
|
23 23
|
|
Overall Study
COMPLETED
|
22 22
|
23 23
|
|
Overall Study
NOT COMPLETED
|
1 1
|
0 0
|
Reasons for withdrawal
| Measure |
PRO-157
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PRO-157
n=23 Participants
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 Participants
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.78 years
STANDARD_DEVIATION 22.8 • n=23 Participants
|
49.65 years
STANDARD_DEVIATION 29.2 • n=23 Participants
|
48.22 years
STANDARD_DEVIATION 25.9 • n=46 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants
|
11 Participants
n=23 Participants
|
20 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
26 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
46 participants
n=46 Participants
|
|
Concomitant medication
|
11 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
23 Participants
n=46 Participants
|
|
Positive culture
|
8 Participants
n=23 Participants
|
16 Participants
n=23 Participants
|
24 Participants
n=46 Participants
|
|
Severe conjunctival secretion
|
4 Participants
n=23 Participants
|
5 Participants
n=23 Participants
|
9 Participants
n=46 Participants
|
|
Severe bulbar conjunctival hyperemia
|
3 Participants
n=23 Participants
|
4 Participants
n=23 Participants
|
7 Participants
n=46 Participants
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)The ocular secretion will be classified as 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The number will be reported according to the rating granted at final visit.
Outcome measures
| Measure |
PRO-157
n=22 Participants
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 Participants
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
Absent
|
20 Participants
|
21 Participants
|
|
Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
Mild
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. Will be graduated using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
Outcome measures
| Measure |
PRO-157
n=22 Participants
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 Participants
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment
Normal
|
17 Participants
|
20 Participants
|
|
Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment
Very mild
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)The global qualification of the investigator constitutes the integral judgment of the clinical picture of the subject, including signs and symptoms, after a routine ophthalmological evaluation and interrogation. It will be classified 0 = cure, 1 = improvement, 2 = no changes compared to before starting treatment, 3 = worsened. It will be registered in the CRF in each of the follow-up visits.
Outcome measures
| Measure |
PRO-157
n=22 Participants
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 Participants
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment
Cure
|
16 Participants
|
19 Participants
|
|
Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment
Improvement
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)The conjunctival secretion sample will be taken prior to the instillation of any medication, the result of the basal crop will be compared against the results of the final crop and the absence of bacterial species that were present in the culture of the baseline visit is considered bacterial eradication.
Outcome measures
| Measure |
PRO-157
n=22 Participants
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 Participants
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Presence of Bacterial Eradication Compared to Baseline Culture Results
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: day 0 to day 17 (visit 0 to security call)The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis
Outcome measures
| Measure |
PRO-157
n=23 Participants
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 Participants
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Adverse Events
Mild Adverse Event
|
25 number of adverse events
|
27 number of adverse events
|
|
Adverse Events
Moderate Adverse Event
|
0 number of adverse events
|
2 number of adverse events
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)The clinical remission in the visits will be evaluated as "Yes" or "No", to report "Yes" it must have a grade of "0" in conjunctival hyperemia and "0" in secretion; otherwise, you must report as "No".
Outcome measures
| Measure |
PRO-157
n=22 Participants
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 Participants
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit
|
15 Participants
|
19 Participants
|
Adverse Events
PRO-157
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Zymar
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-157
n=23 participants at risk
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
Zymar
n=23 participants at risk
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
|
|---|---|---|
|
Eye disorders
Burning sensation
|
82.6%
19/23 • Number of events 19 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
65.2%
15/23 • Number of events 15 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Nervous system disorders
Headache
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.7%
2/23 • Number of events 2 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular Pain
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.7%
2/23 • Number of events 2 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Blepharoedema
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
8.7%
2/23 • Number of events 2 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Palpebral hyperemia
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular irritation
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Tearing
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Pruritus
|
13.0%
3/23 • Number of events 3 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
13.0%
3/23 • Number of events 3 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Cardiac disorders
Preexcitation syndrome
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Transparent Filament Presence
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular dryness
|
4.3%
1/23 • Number of events 1 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/23 • From day 1 (basal visit) to the safety call on day 15 (±2 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 monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
Additional Information
Dr. Alejandra Sanchez-Rios
Medical Affairs Operations Chief
Phone: 33 3001 4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place