Open Angle Glaucoma, Ocular Hypertension
Conditions
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.
Interventions
DRUGBrimonidine Tartrate Ophthalmic Suspension
PDP-716
Three Times Brimonidine Tartrate Ophthalmic Solution
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be male or female, of 2 years of age or older 2. Have open-angle glaucoma or ocular hypertension in both the eyes 3. Be able and willing to follow study instructions and complete all required visits.
Exclusion criteria
1. Females who are pregnant/lactating. 2. Have uncontrolled systemic disease which might interfere with the study 3. Any known allergy or sensitivity to the study medications or their components 4. Any other clinically relevant abnormality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Mean Intraocular Pressure | Week 12 8 AM, 10 AM and 4 PM |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PDP-716 Brimonidine Tartrate Ophthalmic Suspension | 337 |
| Brimonidine Tartrate Ophthalmic Solution Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution | 341 |
| Total | 678 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 14 |
| 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 | Physician Decision | 2 | 2 |
| Overall Study | Protocol Violation | 11 | 8 |
| Overall Study | Withdrawal by Subject | 12 | 6 |
Baseline characteristics
| Characteristic | PDP-716 | Brimonidine Tartrate Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 10.7 | 66.4 years STANDARD_DEVIATION 10.96 | 66.3 years STANDARD_DEVIATION 10.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants | 55 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 283 Participants | 285 Participants | 568 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 167 Participants | 159 Participants | 326 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 162 Participants | 178 Participants | 340 Participants |
| Sex: Female, Male Female | 199 Participants | 200 Participants | 399 Participants |
| Sex: Female, Male Male | 138 Participants | 141 Participants | 279 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 337 | 0 / 341 |
| other Total, other adverse events | 63 / 337 | 38 / 341 |
| serious Total, serious adverse events | 1 / 337 | 3 / 341 |
Outcome results
Primary
Change From Baseline in Mean Intraocular Pressure
Time frame: Week 12 8 AM, 10 AM and 4 PM
Population: Per-Protocol Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PDP-716 | Change From Baseline in Mean Intraocular Pressure | 8 AM +/- 30 min | 20.35 mmHg | Standard Deviation 3.746 |
| PDP-716 | Change From Baseline in Mean Intraocular Pressure | 10 AM +/- 30 min | 17.38 mmHg | Standard Deviation 3.401 |
| PDP-716 | Change From Baseline in Mean Intraocular Pressure | 4 PM +/- 30 min | 17.99 mmHg | Standard Deviation 3.309 |
| Brimonidine Tartrate Ophthalmic Solution | Change From Baseline in Mean Intraocular Pressure | 8 AM +/- 30 min | 20.79 mmHg | Standard Deviation 3.724 |
| Brimonidine Tartrate Ophthalmic Solution | Change From Baseline in Mean Intraocular Pressure | 10 AM +/- 30 min | 18.31 mmHg | Standard Deviation 18.31 |
| Brimonidine Tartrate Ophthalmic Solution | Change From Baseline in Mean Intraocular Pressure | 4 PM +/- 30 min | 17.57 mmHg | Standard Deviation 3.579 |
p-value: 0.0006t-test, 2 sided
p-value: 0.0291t-test, 2 sided
p-value: 0.0002t-test, 2 sided