Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
Interventions
DRUGBrinzolamide/brimonidine ophthalmic suspension
Test product
DRUGSimbrinza 0.2%/1% Ophthalmic Suspension
Reference product
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes 2. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. 3. Adequate wash-out period prior to baseline of any ocular hypotensive medication. 4. Baseline (Day 0/hour 0) pressure ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of pressure between the eyes no greater than 5 mm Hg. 5. Baseline best corrected visual acuity equivalent to 20/200 or better in each eye
Exclusion criteria
1. Females who are pregnant, breast feeding, or planning a pregnancy. 2. Females of childbearing potential who do not agree to utilize an adequate form of contraception 3. Current, or past history of, severe hepatic or renal impairment 4. Current, or history within two months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye 5. Current corneal abnormalities that would prevent accurate readings with the Goldmann applanation tonometer 6. Functionally significant visual field loss 7. Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy 8. Use at any time prior to baseline of an intraocular corticosteroid implant 9. Use within one week prior to baseline of contact lens 10. Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid 11. Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy 12. Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid 13. Having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery) 14. Having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Intra-ocular Pressure | 6 weeks | mean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perrigo Active Brinzolamide/brimonidine ophthalmic suspension: Test product | 221 |
| Reference Active Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product | 226 |
| Total | 447 |
Baseline characteristics
| Characteristic | Reference Active | Perrigo Active | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 157 Participants | 155 Participants | 312 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 66 Participants | 135 Participants |
| Age, Continuous | 66.0 years STANDARD_DEVIATION 10.31 | 66.7 years STANDARD_DEVIATION 10.57 | 66.35 years STANDARD_DEVIATION 5.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 22 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 194 Participants | 199 Participants | 393 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris color Left eye - Dark | 145 participants | 148 participants | 293 participants |
| Iris color Left eye - Light | 81 participants | 73 participants | 154 participants |
| Iris color Right eye - Dark | 145 participants | 147 participants | 292 participants |
| Iris color Right eye - Light | 81 participants | 74 participants | 155 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 63 Participants | 119 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 162 Participants | 148 Participants | 310 Participants |
| Region of Enrollment United States | 226 participants | 221 participants | 447 participants |
| Sex: Female, Male Female | 132 Participants | 122 Participants | 254 Participants |
| Sex: Female, Male Male | 94 Participants | 99 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 221 | 0 / 226 |
| other Total, other adverse events | 32 / 221 | 22 / 226 |
| serious Total, serious adverse events | 2 / 221 | 4 / 226 |
Outcome results
Primary
Mean Change in Intra-ocular Pressure
mean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perrigo Active | Mean Change in Intra-ocular Pressure | 8AM Day 14 | -5.30 mmHG | Standard Deviation 3.181 |
| Perrigo Active | Mean Change in Intra-ocular Pressure | 10AM Day 14 | -6.92 mmHG | Standard Deviation 2.99 |
| Perrigo Active | Mean Change in Intra-ocular Pressure | 8AM Day 42 | -5.07 mmHG | Standard Deviation 2.796 |
| Perrigo Active | Mean Change in Intra-ocular Pressure | 10AM Day 42 | -6.53 mmHG | Standard Deviation 3.129 |
| Reference Active | Mean Change in Intra-ocular Pressure | 10AM Day 42 | -6.37 mmHG | Standard Deviation 3.152 |
| Reference Active | Mean Change in Intra-ocular Pressure | 8AM Day 14 | -5.16 mmHG | Standard Deviation 3.03 |
| Reference Active | Mean Change in Intra-ocular Pressure | 8AM Day 42 | -5.03 mmHG | Standard Deviation 2.997 |
| Reference Active | Mean Change in Intra-ocular Pressure | 10AM Day 14 | -6.57 mmHG | Standard Deviation 3.13 |
95% CI: [-0.71, 0.51]
Comparison: 10AM Day 1495% CI: [-0.86, 0.26]
95% CI: [-0.58, 0.58]
95% CI: [-0.7, 0.47]