Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

Korábbi kezelés

• 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

Más betegség

• 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)

Laborértékek

• 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.

Életkor

• Study eye(s) cannot have clinically significant retinal disease that includes proliferative diabetic retinopathy, vein occlusion, cystoid macular edema, wet age-related macular degeneration

Egyéb

• 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)

• 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.