Glaucoma, Open-AnglePhase 3NCT04024072

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

A Phase 3 study testing Brinzolamide 1% ophthalmic suspension and Azopt 1% Ophthalmic Suspension in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Padagis LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the safety and efficacy of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?: Brinzolamide 1% ophthalmic suspension and Azopt 1% Ophthalmic Suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 495 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2019to 30 Apr 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes
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.
Adequate wash-out period prior to baseline of any ocular hypotensive medication.
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.
Baseline best corrected visual acuity equivalent to 20/200 or better in each eye

Who cannot join

Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception
Current, or past history of, severe hepatic or renal impairment
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
Current corneal abnormalities that would prevent accurate readings with the Goldmann applanation tonometer
Functionally significant visual field loss

Show all 14Show fewer

Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
Use at any time prior to baseline of an intraocular corticosteroid implant
Use within one week prior to baseline of contact lens
Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy
Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
Having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery)
Having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction

Trial locations and contacts

1 site in 1 country.

United States1 site

James D. Branch Ophthalmology
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide Ophthalmic Suspension 1% to Azopt® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes

To compare the safety and efficacy of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: Brinzolamide 1% ophthalmic suspension, Azopt 1% Ophthalmic Suspension
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brinzolamide 1% ophthalmic suspensionDrug
Test product
Azopt 1% Ophthalmic SuspensionDrug
Reference product

Study groups in NCT04024072
Study group	Role	What they receive
Perrigo active	Experimental	Test product Receives: Drug: Brinzolamide 1% ophthalmic suspension
Reference active	Active comparator	Azopt ophthalmic suspension Receives: Drug: Azopt 1% Ophthalmic Suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Intra-ocular Pressure
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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 201930 Apr 2020

First posted18 Jul 2019
Study start24 Jun 2019
Primary completion26 Feb 2020
Study completion30 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 495 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04024072
Sponsor's protocol ID: PRG-NY-19-001
Status last verified: Feb 2023
First submitted: 16 Jul 2019
Last updated: 6 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
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All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide Ophthalmic Suspension 1% to Azopt® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes
ClinicalTrials.gov ID: NCT04024072
Acronym / sponsor ID: PRG-NY-19-001
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 495 participants (actual)
Lead sponsor: Padagis LLCIndustry (pharma, biotech, devices)
Study start: 24 Jun 2019 (actual)
Primary completion: 26 Feb 2020 (actual)
Study completion: 30 Apr 2020 (actual)
First posted: 18 Jul 2019 (actual)
Results: Posted 6 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare the safety and efficacy of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Perrigo active	Experimental	Drug: Brinzolamide 1% ophthalmic suspensionTest product
Reference active	Active comparator	Drug: Azopt 1% Ophthalmic SuspensionAzopt ophthalmic suspension

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes
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.
Adequate wash-out period prior to baseline of any ocular hypotensive medication.
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.
Baseline best corrected visual acuity equivalent to 20/200 or better in each eye

Key exclusion criteria (14 listed)

Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception
Current, or past history of, severe hepatic or renal impairment
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
Current corneal abnormalities that would prevent accurate readings with the Goldmann applanation tonometer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brinzolamide 1% ophthalmic suspensionTest product	Drug	Perrigo active
Azopt 1% Ophthalmic SuspensionReference product	Drug	Reference active

Primary outcome

Mean Change in Intra-ocular Pressure
Time frame: 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.

Results and safety

Results posted to the registry on 6 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Perrigo Active	249	247
Reference Active	246	237

Primary outcome: Mean Change in Intra-ocular Pressure

Time frame: 6 weeks. Mean (Standard Deviation). Unit: mmHG

Measure	Perrigo Active n = 228	Reference Active n = 219
8AM Day 14	-4.25 (2.713)	-3.80 (2.719)
10AM Day 14	-4.22 (2.722)	-4.00 (2.756)
8AM Day 42	-4.43 (2.967)	-4.20 (2.591)
10AM Day 42	-4.05 (2.961)	-4.06 (2.842)

Perrigo Active vs Reference Active: Mean Difference (Net): -0.46 (95% CI -0.93 to 0.01)
Perrigo Active vs Reference Active: Mean Difference (Net): -0.23 (95% CI -0.70 to 0.24)
Perrigo Active vs Reference Active: Mean Difference (Net): -0.24 (95% CI -0.74 to 0.27)

Population analysed: Per-protocol population

Adverse events

Time frame: Day 1 to Day 46. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perrigo Active	0 of 249 (0%)	32 of 249 (12.9%)	0 of 249
Reference Active	1 of 246 (0.4%)	36 of 246 (14.6%)	0 of 246

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Glaucoma, Open-Angle

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Intra-ocular Pressure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.