Eplerenone and IOP in Healthy Adults

Effect of Short-Term Oral Eplerenone on Intraocular Pressure in Healthy Adult Volunteers: A Randomized, Double-Masked, Placebo-Controlled Crossover Study

The goal of this clinical trial is to determine whether eplerenone lowers eye pressure in healthy adults. Eplerenone is a medication approved by the U.S. Food and Drug Administration for other medical conditions. Researchers will compare eplerenone with placebo (a substance containing no active drug) to determine whether eplerenone affects intraocular pressure (IOP). Participants will receive both eplerenone and placebo during different study periods and will have their eye pressure measured throughout the study. Blood pressure, kidney function, and potassium levels will also be monitored for safety.

This randomized, placebo-controlled crossover study will evaluate the effect of eplerenone on intraocular pressure (IOP) in healthy adults. Eplerenone is a selective mineralocorticoid receptor antagonist approved for other medical conditions.

Participants will receive eplerenone and placebo during separate study periods according to the study protocol. IOP will be measured at specified study visits to evaluate changes associated with eplerenone compared with placebo. Safety monitoring will include assessment of blood pressure, kidney function, and serum potassium levels.

Inclusion Criteria:

• Adults aged 18-50 years
• No history of glaucoma or ocular hypertension
• Baseline intraocular pressure between 10-21 mmHg
• Serum creatinine ≤1.3 mg/dL and serum potassium <4.3 mmol/L
• Systolic blood pressure >110 mmHg

Exclusion Criteria:

• Use of topical or systemic steroids
• Renal disease or hyperkalemia
• Concomitant use of strong CYP3A inhibitors, including clarithromycin, erythromycin, ketoconazole, itraconazole, fluconazole, verapamil, diltiazem, or ritonavir
• Pregnancy or breastfeeding
• Use of medications known to affect intraocular pressure, including topical prostaglandin analogs, topical or systemic beta-blockers, topical alpha-2 agonists, topical or systemic carbonic anhydrase inhibitors, topical Rho-kinase inhibitors, or topical parasympathomimetics