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Prostaglandin Analog

AGN-193408 SR for Glaucoma

Phase 1 & 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of either OAG [open-angle glaucoma] (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.
Diagnosis of either OAG [open-angle glaucoma] (ie, primary OAG, pseudoexfoliation glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 24
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of AGN-193408 SR in people with open-angle glaucoma or ocular hypertension. The study will start with an open-label phase to assess safety, then move to a masked, randomized phase to compare AGN-193408 SR to a placebo.

Who is the study for?
This trial is for people with open-angle glaucoma or ocular hypertension in both eyes. Participants must be willing to stop their current eye pressure treatments for the study without risk, as judged by the investigator. They can't join if they've had certain eye procedures recently, use other eye meds, have allergies to study materials, are in another drug/device study, or have a history of specific eye conditions.Check my eligibility
What is being tested?
The trial is testing AGN-193408 SR's safety and effectiveness compared to sham administration (placebo), Lumigan Vehicle (inactive form), and Lumigan (active treatment). It starts with dose escalation then moves into randomized groups where participants don't know which treatment they're getting.See study design
What are the potential side effects?
Possible side effects aren't detailed here but may include typical reactions related to ocular medications such as redness, discomfort at the application site, changes in vision, itching or swelling of the eyes. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with glaucoma or high eye pressure in both eyes.
Select...
I have been diagnosed with glaucoma or high eye pressure in both eyes.
Select...
I have been diagnosed with glaucoma or high eye pressure in both eyes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye
Number of participants experiencing treatment emergent adverse events
Secondary outcome measures
Time to Rescue Treatment or Re-Treatment in the Study Eye

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 3 -Dose BExperimental Treatment4 Interventions
AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered behind the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Group II: Cohort 3 - Dose AExperimental Treatment4 Interventions
AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered behind the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Group III: Cohort 2 -Dose BExperimental Treatment4 Interventions
AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Group IV: Cohort 2 - Dose AExperimental Treatment4 Interventions
AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
Group V: Cohort 1 -Dose AExperimental Treatment2 Interventions
Single dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.
Group VI: Cohort 1 - Dose BExperimental Treatment2 Interventions
Single dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
949 Previous Clinical Trials
496,722 Total Patients Enrolled
4 Trials studying Ocular Hypertension
1,392 Patients Enrolled for Ocular Hypertension
AllerganLead Sponsor
781 Previous Clinical Trials
275,697 Total Patients Enrolled
85 Trials studying Ocular Hypertension
51,186 Patients Enrolled for Ocular Hypertension
ABBVIE INC.Study DirectorAbbVie
389 Previous Clinical Trials
141,513 Total Patients Enrolled
4 Trials studying Ocular Hypertension
1,392 Patients Enrolled for Ocular Hypertension

Media Library

AGN-193408 SR (Prostaglandin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04499248 — Phase 1 & 2
Ocular Hypertension Research Study Groups: Cohort 3 - Dose A, Cohort 3 -Dose B, Cohort 2 -Dose B, Cohort 1 -Dose A, Cohort 2 - Dose A, Cohort 1 - Dose B
Ocular Hypertension Clinical Trial 2023: AGN-193408 SR Highlights & Side Effects. Trial Name: NCT04499248 — Phase 1 & 2
AGN-193408 SR (Prostaglandin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04499248 — Phase 1 & 2
Ocular Hypertension Patient Testimony for trial: Trial Name: NCT04499248 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for the experiment?

"The data hosted on clinicaltrials.gov provides evidence that recruitment for this study is currently occurring; the trial was first made visible to potential participants on November 16th 2020, and last edited October 4th 2022."

Answered by AI

What is the uppermost limit of participants involved in this research?

"AbbVie, the sponsor for this research endeavour, is recruiting 84 patients to participate in their trial. This will take place at Eye Research Foundation in Newport Beach, Missouri and Tekwani Vision Center in Saint Louis, Florida."

Answered by AI

To what extent is this trial being implemented in clinical settings?

"Presently, 45 trial sites are enrolling patients and of those sites, some can be found in Newport Beach, Saint Louis and Stuart. To make the process simpler for participants, it is prudent to select the closest location available."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Virginia
California
Other
How old are they?
18 - 65
What site did they apply to?
Eye Research Foundation
East West Eye Institute
Global Research Management /ID# 241699
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

Need to get some help to control this high blood pressure. I want to help doctors and researchers get the best treatment for the disease.
PatientReceived 1 prior treatment
I'm currently on two medications to lower the pressure in my eyes but they've only been moderately effective.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 1 Day
Most responsive sites:
  1. Northern New Jersey Eye Institute PA /ID# 241545: < 24 hours
~49 spots leftby Aug 2027