Understanding how eye fluid dynamics affect eye pressure in glaucoma patients

Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

This study is testing if certain factors related to eye fluid can help predict how well glaucoma medications work for people with high eye pressure or open-angle glaucoma.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 3 sites (Rochester, Minnesota and 2 other locations)
• Trial ID: NCT04412096 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to identify physiological factors that predict how patients with ocular hypertension or open-angle glaucoma respond to glaucoma medications. By focusing on aqueous humor dynamics, the study will evaluate how variations in these factors influence intraocular pressure (IOP) response and fluctuations. Up to 200 participants will be recruited to test the hypothesis that specific aqueous humor dynamics can serve as predictive biomarkers for treatment outcomes. The study will utilize FDA-approved medications, Timolol and Latanoprost, to assess their effectiveness based on individual patient profiles.

Who should consider this trial

Good fit: Ideal candidates include individuals with untreated ocular hypertension or mild-to-moderate open-angle glaucoma who meet specific inclusion criteria.

Not a fit: Patients who are pregnant, breastfeeding, or have significantly elevated IOP may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for glaucoma patients, improving their outcomes.

How similar studies have performed: While the approach of using aqueous humor dynamics to predict treatment response is innovative, similar studies have shown promise in understanding IOP variations.

Eligibility criteria

Inclusion Criteria:

* Any self-declared ethnicity-race
* Open-angle with one of the following:

  1. Untreated OHT ≥ 21mmHg
  2. Treated OHT with history of IOP ≥ 21 mmHg on 2 prior clinic visits or IOP ≥ 21 mmHg at screening
  3. 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.

Exclusion Criteria:

* 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
* 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 cannot have history of any past SLT or ALT glaucoma laser treatments.
* 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 trauma within the past 6 months, other than uncomplicated cornea abrasion
* Study eye(s) cannot have ocular infection in the past 3 months
* Study eye(s) cannot have clinically significant retinal disease that includes proliferative diabetic retinopathy, vein occlusion, cystoid macular edema, wet age-related macular degeneration
* 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
* Any abnormality preventing reliable fluorophotometry (e.g., corneal scarring or severe dry eye with fluorescein staining)
* Serious hypersensitivity to any components of study medications or risk from treatment (e.g., sulfa drug allergy, bradycardia, severe asthma, or emphysema)
* 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.
* 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

Where this trial is running

Rochester, Minnesota and 2 other locations

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Sayoko Moroi, MD, PhD — Professor and Chair
• Study coordinator: Abigail Larsen

Conditions Glaucoma; OHT - Ocular Hypertension; aqueous humor dynamics; glaucoma; eye diseases; timolol; latanoprost; Adrenergic beta-Antagonists