Eplerenone and IOP in Healthy Adults

Phase 1Not Yet RecruitingNCT07795762

University of Florida30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Intraocular Pressure (IOP)Healthy Adult

Interventions

EplerenoneDRUG

Eplerenone 50 mg administered orally once daily for one week. In this randomized, double-masked crossover study, participants receive eplerenone during one treatment period and matching placebo during the other treatment period, with a two-week washout period between treatments.

Microcrystalline Cellulose NF (placebo)DRUG

Matching placebo capsule containing Microcrystalline Cellulose NF, administered orally once daily for one week. The placebo is prepared by the Investigational Drug Service to match the study intervention for use in the double-masked crossover design.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UF Health Eye Center - The Oaks

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Change in Mean Intraocular Pressure With Eplerenone Compared With Placebo

Mean intraocular pressure (IOP) will be calculated from Goldmann applanation tonometry measurements obtained at approximately 9:00 AM, 12:00 PM, and 3:00 PM at the end of each treatment period. The primary analysis will compare the within-subject difference in mean IOP during eplerenone treatment versus placebo treatment.

Time frame: End of each 1-week treatment period (Day 7 and Day 28)

Central Contacts

Ramin Daneshvar, M.D.

CONTACT

949-413-5593 rdaneshvar@ufl.edu

Alec Murphy, M.D.

CONTACT

770-687-3662 alecmurphy@ufl.edu

Data from ClinicalTrials.gov

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