A Study to Evaluate Aqueous Humor Dynamic Components

Overview

About this study

The purpose of this study is to identify reasons for variations in eye pressure response to glaucoma drugs between individuals. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 30 years of age.
  • Either gender.
  • 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 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 CCT < 480 microns or > than 620 microns.
  • 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 180o, 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/17/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arthur Sit, M.D., M.S.

Open for enrollment

Contact information:

Elainey Hardtke

(507) 538-4122

Hardtke.Elainey@mayo.edu

More information

Publications

Publications are currently not available