Status:
COMPLETED
Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
University of Nebraska
National Eye Institute (NEI)
Conditions:
Glaucoma
OHT - Ocular Hypertension
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief 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 trea...
Detailed Description
This proposal responded to PA-18-351 "Human Subjects Mechanistic and Minimal Risk Studies" and qualifies as a clinical trial. The central hypothesis is that variations in IOP response to glaucoma drug...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2025
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04412096
Start Date
November 23 2020
End Date
May 22 2025
Last Update
August 11 2025
Active Locations (3)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
3
The Ohio State University
Columbus, Ohio, United States, 43212