Trial Outcomes & Findings for Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination (NCT NCT00961649)
NCT ID: NCT00961649
Last Updated: 2013-07-04
Results Overview
The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2013-07-04
Participant Flow
Subjects were recruited from 9 investigational centers in the United States.
Of the 195 enrolled, 25 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (170).
Participant milestones
| Measure |
Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz+Brim
Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brim
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
44
|
44
|
41
|
|
Overall Study
COMPLETED
|
32
|
40
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
5
|
4
|
Reasons for withdrawal
| Measure |
Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz+Brim
Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brim
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
0
|
2
|
|
Overall Study
Inadequate control of IOP
|
0
|
0
|
0
|
1
|
|
Overall Study
Patient has travel plans during holidays
|
0
|
0
|
1
|
0
|
|
Overall Study
Patient left to Mexico-family emergency
|
1
|
0
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
4
|
4
|
4
|
1
|
Baseline Characteristics
Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination
Baseline characteristics by cohort
| Measure |
Brinz/Brim
n=41 Participants
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz+Brim
n=44 Participants
Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz
n=44 Participants
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brim
n=41 Participants
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 to 64 years
|
15 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
21 participants
n=4 Participants
|
76 participants
n=21 Participants
|
|
Age, Customized
≥65 years
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
24 participants
n=5 Participants
|
20 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
44 participants
n=7 Participants
|
44 participants
n=5 Participants
|
41 participants
n=4 Participants
|
170 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: ITT: All subjects who received study drug and had at least 1 scheduled on-therapy study visit.
The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).
Outcome measures
| Measure |
Brinz/Brim
n=41 Participants
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz
n=44 Participants
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brim
n=41 Participants
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
|---|---|---|---|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim
Change from Baseline (BL) at 8 AM
|
-5.5 millimeters mercury (mmHg)
Standard Error 0.51
|
-5.7 millimeters mercury (mmHg)
Standard Error 0.48
|
-4.1 millimeters mercury (mmHg)
Standard Error 0.50
|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim
Change from BL at +2 hours relative to 8 AM dosing
|
-8.5 millimeters mercury (mmHg)
Standard Error 0.51
|
-4.7 millimeters mercury (mmHg)
Standard Error 0.48
|
-5.3 millimeters mercury (mmHg)
Standard Error 0.51
|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim
Change from BL at +7 hours relative to 8 AM dosing
|
-5.4 millimeters mercury (mmHg)
Standard Error 0.51
|
-2.8 millimeters mercury (mmHg)
Standard Error 0.48
|
-3.0 millimeters mercury (mmHg)
Standard Error 0.51
|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim
Change from BL at +9 hours relative to 8 AM dosing
|
-6.8 millimeters mercury (mmHg)
Standard Error 0.51
|
-3.9 millimeters mercury (mmHg)
Standard Error 0.48
|
-5.9 millimeters mercury (mmHg)
Standard Error 0.51
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: PP: All subjects who received study drug, satisfied inclusion/exclusion criteria, and had at least 1 scheduled on-therapy visit. Individual subject visits or data points were excluded if protocol criteria were violated at a subset of the subject's visits and the violations, in the opinion of the Medical Monitor, did not invalidate remaining visits.
The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.
Outcome measures
| Measure |
Brinz/Brim
n=38 Participants
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz
n=41 Participants
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brim
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
|---|---|---|---|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim
Change from Baseline (BL) at 8 AM
|
-5.5 millimeters mercury (mmHg)
Standard Error 0.52
|
-5.7 millimeters mercury (mmHg)
Standard Error 0.50
|
—
|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim
Change from BL at +2 hours relative to 8 AM dosing
|
-8.4 millimeters mercury (mmHg)
Standard Error 0.54
|
-8.3 millimeters mercury (mmHg)
Standard Error 0.52
|
—
|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim
Change from BL at +7 hours relative to 8 AM dosing
|
-5.0 millimeters mercury (mmHg)
Standard Error 0.54
|
-4.4 millimeters mercury (mmHg)
Standard Error 0.52
|
—
|
|
Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim
Change from BL at +9 hours relative to 8 AM dosing
|
-6.3 millimeters mercury (mmHg)
Standard Error 0.55
|
-6.3 millimeters mercury (mmHg)
Standard Error 0.53
|
—
|
Adverse Events
Brinz/Brim
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Brinz+Brim
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Brinz
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Brim
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brinz/Brim
n=41 participants at risk
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz+Brim
n=44 participants at risk
Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz
n=44 participants at risk
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brim
n=41 participants at risk
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
|
General disorders
Chest pain
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
2.3%
1/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
2.3%
1/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
Other adverse events
| Measure |
Brinz/Brim
n=41 participants at risk
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz+Brim
n=44 participants at risk
Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brinz
n=44 participants at risk
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
Brim
n=41 participants at risk
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
|
|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
17.1%
7/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
13.6%
6/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
15.9%
7/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
14.6%
6/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Ocular hyperaemia
|
7.3%
3/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
4.5%
2/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
2.4%
1/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Eye pain
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
6.8%
3/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
4.5%
2/44 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
0.00%
0/41 • Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
|
Additional Information
Matt Walker, PhD, Clinical Project Lead
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER