Evaluation of Safety and Efficacy of PDP-716
Sponsor
Sun Pharma Advanced Research Company Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03450629
Collaborator
(none)
682
47
2
26.6
14.5
0.5
Study Details
Study Description
Brief Summary
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
682 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension
Actual Study Start Date
:
Sep 13, 2018
Actual Primary Completion Date
:
Dec 1, 2020
Actual Study Completion Date
:
Dec 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PDP-716
|
Drug: Brimonidine Tartrate Ophthalmic Suspension
PDP-716
|
| Active Comparator: Brimonidine Tartrate Ophthalmic Solution
|
Drug: Brimonidine Tartrate Ophthalmic Solution
Three Times Brimonidine Tartrate Ophthalmic Solution
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Mean Intraocular Pressure [Week 12 8 AM, 10 AM and 4 PM]
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Be male or female, of 2 years of age or older
-
Have open-angle glaucoma or ocular hypertension in both the eyes
-
Be able and willing to follow study instructions and complete all required visits.
Exclusion Criteria:
-
Females who are pregnant/lactating.
-
Have uncontrolled systemic disease which might interfere with the study
-
Any known allergy or sensitivity to the study medications or their components
-
Any other clinically relevant abnormality
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SPARC Site 4 | Chandler | Arizona | United States | 85225 |
| 2 | SPARC Site 5 | Prescott | Arizona | United States | 86301 |
| 3 | SPARC Site 3 | Sun City | Arizona | United States | 85351 |
| 4 | SPARC Site 38 | Burbank | California | United States | 91506 |
| 5 | SPARC Site 44 | Glendale | California | United States | 91204 |
| 6 | SPARC Site 45 | Glendale | California | United States | 91204 |
| 7 | SPARC Site 43 | Mission Hills | California | United States | 91345 |
| 8 | SPARC Site 1 | Newport Beach | California | United States | 92663 |
| 9 | SPARC Site 14 | Santa Barbara | California | United States | 93110 |
| 10 | SPARC Site 47 | Torrance | California | United States | 90505 |
| 11 | SPARC Site 7 | Colorado Springs | Colorado | United States | 80919 |
| 12 | SPARC Site 11 | Coral Springs | Florida | United States | 33067 |
| 13 | SPARC Site 29 | Deerfield Beach | Florida | United States | 33064 |
| 14 | SPARC Site 34 | Fort Myers | Florida | United States | 33901 |
| 15 | SPARC Site 46 | Hollywood | Florida | United States | 33021 |
| 16 | SPARC Site 21 | Jacksonville | Florida | United States | 32204 |
| 17 | SPARC Site 35 | Miami | Florida | United States | 33126 |
| 18 | SPARC Site 27 | Miami | Florida | United States | 33134 |
| 19 | SPARC Site 10 | Miami | Florida | United States | 33143 |
| 20 | SPARC Site 16 | Miami | Florida | United States | 33145 |
| 21 | SPARC Site 19 | Miami | Florida | United States | 33174 |
| 22 | SPARC Site 25 | Miami | Florida | United States | 33175 |
| 23 | SPARC Site 41 | Pompano Beach | Florida | United States | 33060 |
| 24 | SPARC Site 18 | Tampa | Florida | United States | 33603 |
| 25 | SPARC Site 42 | Atlanta | Georgia | United States | 30349 |
| 26 | SPARC Site 2 | Morrow | Georgia | United States | 30260 |
| 27 | SPARC Site 22 | Roswell | Georgia | United States | 30076 |
| 28 | SPARC Site 12 | Chicago | Illinois | United States | 60619 |
| 29 | SPARC Site 23 | Paducah | Kentucky | United States | 42001 |
| 30 | SPARC Site 40 | Bowie | Maryland | United States | 20715 |
| 31 | SPARC Site 28 | Kansas City | Missouri | United States | 64055 |
| 32 | SPARC Site 48 | Kansas City | Missouri | United States | 64133 |
| 33 | SPARC Site 31 | Saint Louis | Missouri | United States | 63128 |
| 34 | SPARC Site 15 | Poughkeepsie | New York | United States | 12603 |
| 35 | SPARC Site 36 | Rochester | New York | United States | 14618 |
| 36 | SPARC Site 30 | Gastonia | North Carolina | United States | 28054 |
| 37 | SPARC Site 9 | High Point | North Carolina | United States | 27262 |
| 38 | SPARC Site 17 | Winston-Salem | North Carolina | United States | 27101 |
| 39 | SPARC Site 33 | Fargo | North Dakota | United States | 58103 |
| 40 | SPARC Site 37 | Cincinnati | Ohio | United States | 45242 |
| 41 | SPARC Site 8 | Cleveland | Ohio | United States | 44115 |
| 42 | SPARC Site 24 | Cranberry Township | Pennsylvania | United States | 16066 |
| 43 | SPARC Site 32 | Memphis | Tennessee | United States | 38119 |
| 44 | SPARC Site 39 | Houston | Texas | United States | 77008 |
| 45 | SPARC Site 13 | Mission | Texas | United States | 78572 |
| 46 | SPARC Site 20 | San Antonio | Texas | United States | 78215 |
| 47 | SPARC Site 26 | Saint Albans | Vermont | United States | 05478 |
Sponsors and Collaborators
- Sun Pharma Advanced Research Company Limited
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT03450629
Other Study ID Numbers:
- CLR_16_33
First Posted:
Mar 1, 2018
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PDP-716 | Brimonidine Tartrate Ophthalmic Solution |
|---|---|---|
| Arm/Group Description | Brimonidine tartrate 0.35% ophthalmic suspension (SPARC), QD | Brimonidine tartrate 0.1% ophthalmic solution (Alphagan P® 0.1%), TID |
| Period Title: Overall Study | ||
| STARTED | 341 | 341 |
| COMPLETED | 293 | 307 |
| NOT COMPLETED | 48 | 34 |
Baseline Characteristics
| Arm/Group Title | PDP-716 | Brimonidine Tartrate Ophthalmic Solution | Total |
|---|---|---|---|
| Arm/Group Description | Brimonidine Tartrate Ophthalmic Suspension | Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution | Total of all reporting groups |
| Overall Participants | 337 | 341 | 678 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.2
(10.70)
|
66.4
(10.96)
|
66.3
(10.82)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
199
59.1%
|
200
58.7%
|
399
58.8%
|
| Male |
138
40.9%
|
141
41.3%
|
279
41.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
52
15.4%
|
55
16.1%
|
107
15.8%
|
| Not Hispanic or Latino |
283
84%
|
285
83.6%
|
568
83.8%
|
| Unknown or Not Reported |
2
0.6%
|
1
0.3%
|
3
0.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
4
1.2%
|
0
0%
|
4
0.6%
|
| Asian |
4
1.2%
|
2
0.6%
|
6
0.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
167
49.6%
|
159
46.6%
|
326
48.1%
|
| White |
162
48.1%
|
178
52.2%
|
340
50.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
2
0.6%
|
2
0.3%
|
Outcome Measures
| Title | Change From Baseline in Mean Intraocular Pressure |
|---|---|
| Description | |
| Time Frame | Week 12 8 AM, 10 AM and 4 PM |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol Population |
| Arm/Group Title | PDP-716 | Brimonidine Tartrate Ophthalmic Solution |
|---|---|---|
| Arm/Group Description | Brimonidine Tartrate Ophthalmic Suspension | Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution |
| Measure Participants | 258 | 265 |
| 8 AM +/- 30 min |
20.35
(3.746)
|
20.79
(3.724)
|
| 10 AM +/- 30 min |
17.38
(3.401)
|
18.31
(18.31)
|
| 4 PM +/- 30 min |
17.99
(3.309)
|
17.57
(3.579)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PDP-716, Brimonidine Tartrate Ophthalmic Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | 8 AM +/- 30 min | |
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PDP-716, Brimonidine Tartrate Ophthalmic Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | 10 AM +/- 30 min | |
| Statistical Test of Hypothesis | p-Value | 0.0291 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PDP-716, Brimonidine Tartrate Ophthalmic Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | 4 PM +/- 30 min | |
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | 12 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | PDP-716 | Brimonidine Tartrate Ophthalmic Solution | ||
| Arm/Group Description | Brimonidine Tartrate Ophthalmic Suspension | Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution | ||
All Cause Mortality |
||||
| PDP-716 | Brimonidine Tartrate Ophthalmic Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/337 (0%) | 0/341 (0%) | ||
Serious Adverse Events |
||||
| PDP-716 | Brimonidine Tartrate Ophthalmic Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/337 (0.3%) | 3/341 (0.9%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 0/337 (0%) | 0 | 1/341 (0.3%) | 1 |
| Coronary artery disease | 0/337 (0%) | 0 | 1/341 (0.3%) | 1 |
| Palpitations | 0/337 (0%) | 0 | 1/341 (0.3%) | 1 |
| Infections and infestations | ||||
| Appendicitis | 1/337 (0.3%) | 1 | 0/341 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Large cell lung cancer | 0/337 (0%) | 0 | 1/341 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| PDP-716 | Brimonidine Tartrate Ophthalmic Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 63/337 (18.7%) | 38/341 (11.1%) | ||
| Eye disorders | ||||
| Conjunctival hyperaemia | 8/337 (2.4%) | 8 | 6/341 (1.8%) | 6 |
| Vision blurred | 9/337 (2.7%) | 9 | 0/341 (0%) | 0 |
| Infections and infestations | ||||
| Conjunctivitis | 15/337 (4.5%) | 15 | 11/341 (3.2%) | 11 |
| Nervous system disorders | ||||
| Somnolence | 32/337 (9.5%) | 32 | 21/341 (6.2%) | 21 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Head, Clinical Developmnt |
|---|---|
| Organization | Sun Pharma Advanced Research Company Limited |
| Phone | 912266455645 |
| clinical.trials@sparcmail.com |
Responsible Party:
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT03450629
Other Study ID Numbers:
- CLR_16_33
First Posted:
Mar 1, 2018
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022