Trial · NCT04024072
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
NCT04024072, Phase 3, Completed, Padagis LLC; results first posted 2023-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes. Trials, record NCT04024072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04024072
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
- NCT number
- NCT04024072
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 495 participants, actual
- Lead sponsor
- Padagis LLC
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Interventions
- Brinzolamide 1% ophthalmic suspension, Azopt 1% Ophthalmic Suspension
- First posted
- 2019-07-18
- Last updated
- 2023-03-06
- Results first posted
- 2023-03-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Intra-ocular Pressure | 6 weeks | mean change in intra-ocular pressure of both eyes 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Intra-ocular Pressure | 6 weeks | Per-protocol population | mmHG | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Intra-ocular Pressure | Perrigo Active | 8AM Day 14 | -4.25 | Standard Deviation 2.713 | mmHG |
| Mean Change in Intra-ocular Pressure | Reference Active | 8AM Day 14 | -3.80 | Standard Deviation 2.719 | mmHG |
| Mean Change in Intra-ocular Pressure | Perrigo Active | 10AM Day 14 | -4.22 | Standard Deviation 2.722 | mmHG |
| Mean Change in Intra-ocular Pressure | Reference Active | 10AM Day 14 | -4.00 | Standard Deviation 2.756 | mmHG |
| Mean Change in Intra-ocular Pressure | Perrigo Active | 8AM Day 42 | -4.43 | Standard Deviation 2.967 | mmHG |
| Mean Change in Intra-ocular Pressure | Reference Active | 8AM Day 42 | -4.20 | Standard Deviation 2.591 | mmHG |
| Mean Change in Intra-ocular Pressure | Perrigo Active | 10AM Day 42 | -4.05 | Standard Deviation 2.961 | mmHG |
| Mean Change in Intra-ocular Pressure | Reference Active | 10AM Day 42 | -4.06 | Standard Deviation 2.842 | mmHG |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Perrigo Active | 249 | |
| Overall Study | STARTED | Reference Active | 246 | |
| Overall Study | COMPLETED | Perrigo Active | 247 | |
| Overall Study | COMPLETED | Reference Active | 237 | |
| Overall Study | NOT COMPLETED | Perrigo Active | 2 | |
| Overall Study | NOT COMPLETED | Reference Active | 9 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | vision blurred | Eye disorders | Perrigo Active | 9 | 249 | 9 |
| other | vision blurred | Eye disorders | Reference Active | 15 | 246 | 15 |
| other | Dysgeusia | Nervous system disorders | Perrigo Active | 23 | 249 | 23 |
| other | Dysgeusia | Nervous system disorders | Reference Active | 21 | 246 | 21 |
| serious | Upper respiratory tract infection | Infections and infestations | Perrigo Active | 249 | ||
| serious | Upper respiratory tract infection | Infections and infestations | Reference Active | 1 | 246 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perrigo Active | 0 | 249 |
| Total, all-cause mortality | Reference Active | 0 | 246 |
| Total, other adverse events | Perrigo Active | 32 | 249 |
| Total, other adverse events | Reference Active | 36 | 246 |
| Total, serious adverse events | Perrigo Active | 0 | 249 |
| Total, serious adverse events | Reference Active | 1 | 246 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Perrigo Active vs Reference Active: deaths from any cause | Trial comparisons |
| Perrigo Active vs Reference Active: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04024072
GET https://conductscience.org/api/trials/v1/NCT04024072/registered