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NCT04412096 · ClinicalTrials.gov registry record · Phase 4
Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
A Phase 4 study of Glaucoma and OHT - Ocular Hypertension, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 59
- Enrollment target
- 3
- Study locations
NCT04412096: Completed Phase 4 study of Glaucoma and OHT - Ocular Hypertension, sponsored by Ohio State University.
NCT04412096 is a Phase 4 study of Glaucoma and OHT - Ocular Hypertension that has completed, run by Ohio State University. The registered enrollment target is 59 participants, below the 910-participant average among 92 other Glaucoma trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04412096, a Phase 4 study of Glaucoma and OHT - Ocular Hypertension, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 59 participants
- Enrollment target
- 3
- Study locations
Study Summary
Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and-error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.
Primary Outcome
Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.
Conditions Studied
Interventions
- DRUG Latanoprost 0.005% Ophthalmic Solution
- DRUG Timolol 0.5% ophthalmic solution
Study Locations (3)
Minnesota
- Mayo Clinic - Rochester
Nebraska
- University of Nebraska Medical Center - Omaha
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2025-05-22 |
| Phase | Phase 4 |
What the finished NCT04412096 record still lists
NCT04412096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 910-participant average among 92 other Glaucoma trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Glaucoma appearing as the primary indexed condition, and to 2 interventions - of which Latanoprost 0.005% Ophthalmic Solution is the first listed.
NCT04412096 reports a single indexed study location in Minnesota, Nebraska, Ohio.
Frequently Asked Questions
What is clinical trial NCT04412096 about?
NCT04412096 is a clinical study titled "Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance". Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and-error approaches to glaucoma management are inefficient and have not addre...
What is the current status of trial NCT04412096?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2020-11-23. Estimated completion is 2025-05-22.
What conditions does trial NCT04412096 study?
This clinical trial studies the following conditions: Glaucoma, OHT - Ocular Hypertension.
What interventions are being tested in trial NCT04412096?
The interventions under investigation include: Latanoprost 0.005% Ophthalmic Solution (DRUG), Timolol 0.5% ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT04412096?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04412096 being conducted?
This trial has 3 study locations across Minnesota, Nebraska, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04412096's enrollment target sits among peer trials
59 59th of 92 higher than 34 of 92 other Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glaucoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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