PRO-157: Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.

• Sponsor: Laboratorios Sophia S.A de C.V. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03696342
• Collaborator: (none)
• Enrollment: 46
• Locations: 6
• Arms: 2
• Actual Duration (Months): 17.7
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Phase III clinical study of non-inferiority, multicenter, double-blind, with comparative group, of parallel groups and randomized. about a ophthalmic topical antibiotic for the treatment of bacterial conjunctivitis.

Goal:To compare the efficacy of the ophthalmic solution of pazufloxacin 0.6%, against the ophthalmic solution of gatifloxacin 0.3%, in the treatment of acute bacterial conjunctivitis.

Hypothesis:the ophthalmic solution PRO-157 is not inferior in the treatment of bacterial conjunctivitis, compared to the ophthalmic solution of gatifloxacin 0.3%, by means of the clinical remission of the disease.

Number of patients:

160 patients, each one will provide an eye for efficacy analysis, divided into 2 groups (80 eyes per group).

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Bacterial	Drug: Pazufloxacin; Drug: Zymar	Phase 3

Detailed Description

The study subjects will be recruited from various research centers in western and central Mexico.

Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes.

The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days.

The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico.

The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed.

To verify the integrity, veracity and reliability of the data entered into the e-CRF, the monitors of each center will check the information uploaded to the portal with that reported in the source document of the principal investigator (PI), such as clinical notes, clinical history and documents. and formats attached to the research protocol, physical case report format, as well as those provided by the sponsor to the PI (subject's diary and quality and satisfaction survey).

The e-CRF used for this clinical study is provided by an internationally certified provider with the highest quality standards, protection of information under current regulations and confidentiality guarantee. The information that the PIs enter into the e-CRF is collated and verified by the clinical monitors and by the service provider's personnel, later reviewed and approved by the medical ophthalmologist researcher and by the Clinical Security Pharmacologist, who authorize the monitored data of clinical information and safety of the study molecule, respectively.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: clinical study of non-inferiority, multicenter, double-blind, with comparative group randomizedclinical study of non-inferiority, multicenter, double-blind, with comparative group randomized
• Masking: Double (Participant, Investigator)
• Masking Description: In addition, the statistical analysis will be carried out in a blinded manner in the case of a partial and final analysis. The masking will be done using boxes in the primary packaging identical in the two groups and relabelling the bottles of both interventions. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the assignment number.
• Primary Purpose: Treatment
• Official Title: Clinical Study of the Efficacy of the Ophthalmic Solution of Pazufloxacin 0.6% (PRO-157) for the Treatment of Acute Bacterial Conjunctivitis, Compared to the Ophthalmic Solution of Gatifloxacin 0.3%.
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Mar 24, 2020
• Actual Study Completion Date: Mar 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.; Other Names: PRO-157
Active Comparator: 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.	Drug: 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.; Other Names: gatifloxacin

Outcome Measures

Primary Outcome Measures

1. Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment [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.

2. Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment [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.

Secondary Outcome Measures

1. Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment [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.

2. Presence of Bacterial Eradication Compared to Baseline Culture Results [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.

3. Adverse Events [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

4. Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit [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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed informed consent.

• Age ≥ 1 year.

• Both genders.

• Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia

Exclusion Criteria:

• Pregnant women, lactating or planning to become pregnant.

• Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.

• Participation in another clinical research study ≤ 30 days before the baseline visit.

• Previous participation in this same study.

• That they can not comply with their attendance at appointments or with all the requirements of the protocol.

• Single eye

• Presence of corneal abrasion or corneal ulceration in the study eye.

• History Users of contact lenses who are not willing to suspend their use during the study.

• Users of any formulation with ophthalmic application, including lubricants, that can not, or do not want to suspend it during the study.

• Antecedents of eye surgery 6 weeks prior to study entry.

• Viral or allergic conjunctivitis.

• Active uveitis.

• Active ulcerative keratitis.

• Recurrent corneal erosion syndrome

• Antecedent of hypersensitivity or allergy to fluoroquinolones.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Consultorio Dra. Patricia Culebro Solano	Guadalajara	Jalisco	Mexico	44100
2	Juan Carlos Ochoa Tavares	Guadalajara	Jalisco	Mexico	44600
3	Samuel altamirano Vallejo	Guadalajara	Jalisco	Mexico	44670
4	Centro de investigación Medica Aguascalientes	Aguascalientes		Mexico	20116
5	Juan Carlos Serna Ojeda (INBIOMEDyC)	Aguascalientes		Mexico	20190
6	Instituto Nacional de Pediatria	Mexico City		Mexico	04530

Sponsors and Collaborators

• Laboratorios Sophia S.A de C.V.

Investigators

• Study Director: Leopoldo Baiza Durán, MD, Laboratorios Sophia S.A de C.V.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 19, 2018

More Information

Publications

None provided.

• Responsible Party: Laboratorios Sophia S.A de C.V.
• ClinicalTrials.gov Identifier: NCT03696342
• Other Study ID Numbers: SOPH157-0217/III
• First Posted: Oct 4, 2018
• Last Update Posted: Aug 24, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Laboratorios Sophia S.A de C.V.: pazufloxacin; PRO-157; Fluoroquinolones
• Additional relevant MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis; Gatifloxacin; Pazufloxacin

Study Results

Participant Flow

Arm/Group Title	PRO-157	Zymar
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	23	23
COMPLETED	22	23
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	PRO-157	Zymar	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	23	23	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.78 (22.8)	49.65 (29.2)	48.22 (25.9)
Sex: Female, Male (Count of Participants)
Female	9 39.1%	11 47.8%	20 43.5%
Male	14 60.9%	12 52.2%	26 56.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Mexico	23 100%	23 100%	46 100%
Concomitant medication (Count of Participants)
Count of Participants [Participants]	11 47.8%	12 52.2%	23 50%
Positive culture (Count of Participants)
Count of Participants [Participants]	8 34.8%	16 69.6%	24 52.2%
Severe conjunctival secretion (Count of Participants)
Count of Participants [Participants]	4 17.4%	5 21.7%	9 19.6%
Severe bulbar conjunctival hyperemia (Count of Participants)
Count of Participants [Participants]	3 13%	4 17.4%	7 15.2%

Outcome Measures

1. Primary Outcome

Title	Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
Description	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.
Time Frame	will be evaluated at the end of the treatment (day 8, final visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-157	Zymar
Arm/Group Description	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.	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.
Measure Participants	22	23
Absent	20 87%	21 91.3%
Mild	2 8.7%	2 8.7%

2. Primary Outcome

Title	Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment
Description	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.
Time Frame	will be evaluated at the end of the treatment (day 8, final visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-157	Zymar
Arm/Group Description	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.	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.
Measure Participants	22	23
Normal	17 73.9%	20 87%
Very mild	5 21.7%	3 13%

3. Secondary Outcome

Title	Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment
Description	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.
Time Frame	will be evaluated at the end of the treatment (day 8, final visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-157	Zymar
Arm/Group Description	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.	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.
Measure Participants	22	23
Cure	16 69.6%	19 82.6%
Improvement	6 26.1%	4 17.4%

4. Secondary Outcome

Title	Presence of Bacterial Eradication Compared to Baseline Culture Results
Description	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.
Time Frame	will be evaluated at the end of the treatment (day 8, final visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-157	Zymar
Arm/Group Description	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.	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.
Measure Participants	22	23
Count of Participants [Participants]	19 82.6%	22 95.7%

5. Secondary Outcome

Title	Adverse Events
Description	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
Time Frame	day 0 to day 17 (visit 0 to security call)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-157	Zymar
Arm/Group Description	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.	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.
Measure Participants	23	23
Mild Adverse Event	25	27
Moderate Adverse Event	0	2

6. Secondary Outcome

Title	Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit
Description	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".
Time Frame	will be evaluated at the end of the treatment (day 8, final visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-157	Zymar
Arm/Group Description	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.	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.
Measure Participants	22	23
Count of Participants [Participants]	15 65.2%	19 82.6%

Adverse Events

Time Frame	From day 1 (basal visit) to the safety call on day 15 (±2 days)
Adverse Event Reporting Description	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.
Arm/Group Title	PRO-157		Zymar
Arm/Group Description	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.		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.
All Cause Mortality
	PRO-157		Zymar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	PRO-157		Zymar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	PRO-157		Zymar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/23 (87%)		18/23 (78.3%)
Cardiac disorders
Preexcitation syndrome	0/23 (0%)	0	1/23 (4.3%)	1
Eye disorders
Burning sensation	19/23 (82.6%)	19	15/23 (65.2%)	15
Ocular Pain	0/23 (0%)	0	2/23 (8.7%)	2
Blepharoedema	0/23 (0%)	0	2/23 (8.7%)	2
Palpebral hyperemia	0/23 (0%)	0	1/23 (4.3%)	1
Ocular irritation	0/23 (0%)	0	1/23 (4.3%)	1
Tearing	1/23 (4.3%)	1	1/23 (4.3%)	1
Pruritus	3/23 (13%)	3	3/23 (13%)	3
Transparent Filament Presence	1/23 (4.3%)	1	0/23 (0%)	0
Ocular dryness	1/23 (4.3%)	1	0/23 (0%)	0
Musculoskeletal and connective tissue disorders
Sprain	0/23 (0%)	0	1/23 (4.3%)	1
Nervous system disorders
Headache	0/23 (0%)	0	2/23 (8.7%)	2

Limitations/Caveats

This trial was terminated early due to the sponsor's convenience in the pipeline followed by the studied product. A small sample renders this results as merely descriptive.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.