Trial · NCT04944290

To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes

NCT04944290, Phase 3, Completed, Padagis LLC; results first posted 2025-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes. Trials, record NCT04944290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04944290

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
NCT number: NCT04944290
Status: Completed
Phases: Phase 3
Enrollment: 447 participants, actual
Lead sponsor: Padagis LLC
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Interventions: Brinzolamide/brimonidine ophthalmic suspension, Simbrinza 0.2%/1% Ophthalmic Suspension
First posted: 2021-06-29
Last updated: 2025-04-02
Results first posted: 2025-04-02

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 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

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		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	-5.30	Standard Deviation 3.181	mmHG
Mean Change in Intra-ocular Pressure	Reference Active	8AM Day 14	-5.16	Standard Deviation 3.030	mmHG
Mean Change in Intra-ocular Pressure	Perrigo Active	10AM Day 14	-6.92	Standard Deviation 2.990	mmHG
Mean Change in Intra-ocular Pressure	Reference Active	10AM Day 14	-6.57	Standard Deviation 3.130	mmHG
Mean Change in Intra-ocular Pressure	Perrigo Active	8AM Day 42	-5.07	Standard Deviation 2.796	mmHG
Mean Change in Intra-ocular Pressure	Reference Active	8AM Day 42	-5.03	Standard Deviation 2.997	mmHG
Mean Change in Intra-ocular Pressure	Perrigo Active	10AM Day 42	-6.53	Standard Deviation 3.129	mmHG
Mean Change in Intra-ocular Pressure	Reference Active	10AM Day 42	-6.37	Standard Deviation 3.152	mmHG

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Perrigo Active	221
Overall Study	STARTED	Reference Active	226
Overall Study	COMPLETED	Perrigo Active	204
Overall Study	COMPLETED	Reference Active	214
Overall Study	NOT COMPLETED	Perrigo Active	17
Overall Study	NOT COMPLETED	Reference Active	12

Source ClinicalTrials.gov

Adverse events20

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	16	221	221
other	Vision blurred	Eye disorders	Reference Active	12	226	226
other	Dysgeusia	Nervous system disorders	Perrigo Active	16	221	221
other	Dysgeusia	Nervous system disorders	Reference Active	10	226	226
serious	Cholecystitis	Hepatobiliary disorders	Perrigo Active	1	221	1
serious	Cholecystitis	Hepatobiliary disorders	Reference Active	0	226	0
serious	coronary heart disease	Cardiac disorders	Perrigo Active	0	221	0
serious	coronary heart disease	Cardiac disorders	Reference Active	1	226	1
serious	subarachnoid hemorrhage	Nervous system disorders	Perrigo Active	0	221	0
serious	subarachnoid hemorrhage	Nervous system disorders	Reference Active	1	226	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Perrigo Active	1	221
Total, all-cause mortality	Reference Active	0	226
Total, other adverse events	Perrigo Active	32	221
Total, other adverse events	Reference Active	22	226
Total, serious adverse events	Perrigo Active	2	221
Total, serious adverse events	Reference Active	4	226

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04944290

GET https://conductscience.org/api/trials/v1/NCT04944290/registered

API reference For AI assistants