Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance

2020H0284

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.

2020-11-23

2024-07-01

2024-08-31

Recruiting

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The overall study design is a prospective, open-label, randomized clinical trial with randomized order of 7-day treatments with timolol followed by a washout period and then with latanoprost or vice versa. Participants will undergo two 7-day treatments, with timolol 0.5% (1 drop two times daily) and latanoprost 0.005% (1 drop daily in the evening). The order of timolol and latanoprost will be randomized. The IOP, AHD parameters and IOP fluctuation will be compared in an individual under three conditions: (i) baseline, and after a randomized order of 7-day treatment of (ii) timolol 0.5% 1 drop two times daily and (iii) latanoprost 0.005% 1 drop in the evening separated by a 6-week washout period. The overall time commitment to complete these procedures is three to four months.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-01-19