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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had corneal graft surgery or specific eye surgeries other than for astigmatism.I have been diagnosed with glaucoma or high eye pressure in both eyes.I have had a specific eye surgery in the lower part of my iris.I have been diagnosed with glaucoma or high eye pressure in both eyes.I am not allergic to any study drugs, their components, or related materials.You have had an implant in your eye as part of a previous study.I plan to use eye drops not allowed by the study.I expect to need eye surgery during the study.I have had swelling in the retina of one or both eyes.I have had complex cataract or lens surgery with complications.You have significant loss of vision in the eye being studied, or have shown ongoing loss of vision in the year before the study.You normally wear contact lenses, but you'll need to stop wearing them before certain study visits and before and after receiving treatment.I expect to use corticosteroids for my eyes or throughout my body during the study.I have had surgery for glaucoma in at least one eye.I have not had laser eye surgery in the past 6 months.I have not had eye surgery in the last 4 months.The thickness of the center part of your eye's cornea is too thin or too thick.I have had eye infections caused by herpes viruses.I have been diagnosed with glaucoma or high eye pressure in both eyes.I have had a significant eye injury in the past.I have a history of narrow angle or closed angle glaucoma in one eye.The participant is willing to withhold their treatments according to the study requirements, and in the opinion of the investigator, they can do so without any significant risk.
- Group 1: Cohort 3 - Dose A
- Group 2: Cohort 3 -Dose B
- Group 3: Cohort 2 -Dose B
- Group 4: Cohort 1 -Dose A
- Group 5: Cohort 2 - Dose A
- Group 6: Cohort 1 - Dose B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 1 Day
Most responsive sites:
- Northern New Jersey Eye Institute PA /ID# 241545: < 24 hours
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