Trial Outcomes & Findings for Evaluation of Safety and Efficacy of PDP-716 (NCT NCT03450629)
NCT ID: NCT03450629
Last Updated: 2022-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
682 participants
Primary outcome timeframe
Week 12 8 AM, 10 AM and 4 PM
Results posted on
2022-02-15
Participant Flow
Participant milestones
| Measure |
PDP-716
Brimonidine tartrate 0.35% ophthalmic suspension (SPARC), QD
|
Brimonidine Tartrate Ophthalmic Solution
Brimonidine tartrate 0.1% ophthalmic solution (Alphagan P® 0.1%), TID
|
|---|---|---|
|
Overall Study
STARTED
|
341
|
341
|
|
Overall Study
COMPLETED
|
293
|
307
|
|
Overall Study
NOT COMPLETED
|
48
|
34
|
Reasons for withdrawal
| Measure |
PDP-716
Brimonidine tartrate 0.35% ophthalmic suspension (SPARC), QD
|
Brimonidine Tartrate Ophthalmic Solution
Brimonidine tartrate 0.1% ophthalmic solution (Alphagan P® 0.1%), TID
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
14
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
0
|
1
|
|
Overall Study
Non-Compliance With Study Drug
|
2
|
1
|
|
Overall Study
Protocol Violation
|
11
|
8
|
|
Overall Study
Withdrawal by Subject
|
12
|
6
|
Baseline Characteristics
Evaluation of Safety and Efficacy of PDP-716
Baseline characteristics by cohort
| Measure |
PDP-716
n=337 Participants
Brimonidine Tartrate Ophthalmic Suspension
|
Brimonidine Tartrate Ophthalmic Solution
n=341 Participants
Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
|
Total
n=678 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 10.70 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 10.96 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
283 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
568 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 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
|
167 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 8 AM, 10 AM and 4 PMPopulation: Per-Protocol Population
Outcome measures
| Measure |
PDP-716
n=258 Participants
Brimonidine Tartrate Ophthalmic Suspension
|
Brimonidine Tartrate Ophthalmic Solution
n=265 Participants
Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
|
|---|---|---|
|
Change From Baseline in Mean Intraocular Pressure
8 AM +/- 30 min
|
20.35 mmHg
Standard Deviation 3.746
|
20.79 mmHg
Standard Deviation 3.724
|
|
Change From Baseline in Mean Intraocular Pressure
10 AM +/- 30 min
|
17.38 mmHg
Standard Deviation 3.401
|
18.31 mmHg
Standard Deviation 18.31
|
|
Change From Baseline in Mean Intraocular Pressure
4 PM +/- 30 min
|
17.99 mmHg
Standard Deviation 3.309
|
17.57 mmHg
Standard Deviation 3.579
|
Adverse Events
PDP-716
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Brimonidine Tartrate Ophthalmic Solution
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PDP-716
n=337 participants at risk
Brimonidine Tartrate Ophthalmic Suspension
|
Brimonidine Tartrate Ophthalmic Solution
n=341 participants at risk
Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.30%
1/337 • Number of events 1 • 12 weeks
|
0.00%
0/341 • 12 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/337 • 12 weeks
|
0.29%
1/341 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/337 • 12 weeks
|
0.29%
1/341 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/337 • 12 weeks
|
0.29%
1/341 • Number of events 1 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer
|
0.00%
0/337 • 12 weeks
|
0.29%
1/341 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
PDP-716
n=337 participants at risk
Brimonidine Tartrate Ophthalmic Suspension
|
Brimonidine Tartrate Ophthalmic Solution
n=341 participants at risk
Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
9.5%
32/337 • Number of events 32 • 12 weeks
|
6.2%
21/341 • Number of events 21 • 12 weeks
|
|
Eye disorders
Conjunctival hyperaemia
|
2.4%
8/337 • Number of events 8 • 12 weeks
|
1.8%
6/341 • Number of events 6 • 12 weeks
|
|
Infections and infestations
Conjunctivitis
|
4.5%
15/337 • Number of events 15 • 12 weeks
|
3.2%
11/341 • Number of events 11 • 12 weeks
|
|
Eye disorders
Vision blurred
|
2.7%
9/337 • Number of events 9 • 12 weeks
|
0.00%
0/341 • 12 weeks
|
Additional Information
Head, Clinical Developmnt
Sun Pharma Advanced Research Company Limited
Phone: 912266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER