NCT04412096CompletedPhase 4
Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 29 May 2020
- Start date
- 23 Nov 2020
- Primary completion date
- 22 May 2025
- Lead sponsor
- Ohio State University
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT04412096
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 59
- From 23 Nov 2020 to the primary completion date, 22 May 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prohibited meds during study: cannabis products, brimonidine 0.025% (Lumify), bimatoprost 0.03% for eyelash growth (Latisse), topical ocular and peri-ocular steroids, oral steroids
Other illness
- History of acute angle closure crisis in either eye
- History of glaucoma incisional surgery (e.g., trabeculectomy, glaucoma drainage implant, Xen gel stent) in study eye(s)
- History of minimally invasive glaucoma surgery (MIGS, e.g., angle surgery, Cypass) in study eye(s)
- History of any cycloablation surgery (e.g., micropulse or diode transcleral or endoscopic cyclophotocoagulation) in study eye(s)
- Study eye(s) cannot have any history of refractive surgery
- Study eye(s) cannot have any history of herpetic infection of the cornea
- Study eye(s) cannot have chronic or recurrent inflammatory eye disease
- Study eye(s) cannot have ocular infection in the past 3 months
- History of intraocular or peri-ocular injections in study eye(s) within 3 months
- History of oral steroid use within 30 days of screening Visit 1
- Serious hypersensitivity to any components of study medications or risk from treatment (e.g., sulfa drug allergy, bradycardia, severe asthma, or emphysema)
Lab values
- Study eye cannot have history of any past SLT or ALT glaucoma laser treatments.
- Participants must be on minimum 30-day stable regimen prior to Visit 1 for a systemic medication that may affect IOP (i.e., sympathomimetics, beta-blockers, alpha-adrenergic agonists and blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.). Any change of such medication during the study will result in exclusion.
Age
- Study eye(s) cannot have clinically significant retinal disease that includes proliferative diabetic retinopathy, vein occlusion, cystoid macular edema, wet age-related macular degeneration
Other
- Women who are pregnant or breastfeeding
- IOP ≥ 38 in study eye(s) or at discretion of the clinician
- Refusal to remove contact lenses
- Advanced visual field loss (MD ≤ -16 dB) or threat to fixation in study eye(s) or at discretion of the clinician
- Study eye(s) with any sign of Fuchs cornea dystrophy as noted clinically with guttae and corneal edema
- Narrow angle of ≤ Shaffer grade 2 for 180 degrees, peripheral synechiae, or peripheral iridotomy in either eye
- Study eye(s) cannot have ocular trauma within the past 6 months, other than uncomplicated cornea abrasion
- Any abnormality preventing reliable fluorophotometry (e.g., corneal scarring or severe dry eye with fluorescein staining)
Who the study is looking for
- Any self-declared ethnicity-race
- Open-angle with one of the following:
- Untreated OHT ≥ 21mmHg
- Treated OHT with history of IOP ≥ 21 mmHg on 2 prior clinic visits or IOP ≥ 21 mmHg at screening
- Mild-to-moderate stage open-angle glaucoma based on history of untreated IOP ≥ 21 mmHg
- Reliable Humphrey visual field test result within previous 1 year
- Open on gonioscopy within previous 1 year
- At least one eye must be phakic
- Able to cooperate for aqueous humor dynamic procedures
- Able to participate on site over the multi-visit study period
- Contact lenses must be removed before topical fluorescein instillation and remain out until study testing the following day is completed.
- Contact lenses must be removed for the entire duration of the study visits.
- All study medication must be used without contact lenses in the eyes.
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.