Eplerenone and IOP in Healthy Adults

NCT07795762 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB202600169
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Pressure (IOP); Healthy Adult

Keywords

Eplerenone; Intraocular pressure; IOP; Mineralocorticoid receptor antagonist; Healthy volunteers; Healthy adults; Placebo-controlled; Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Eplerenone Then Placebo

EXPERIMENTAL

Participants receive oral eplerenone 50 mg once daily for one week, followed by a two-week washout period, and then matching placebo once daily for one week.

Drug: Eplerenone; Drug: Microcrystalline Cellulose NF (placebo)

Placebo Then Eplerenone

EXPERIMENTAL

Participants receive matching placebo once daily for one week, followed by a two-week washout period, and then oral eplerenone 50 mg once daily for one week.

Drug: Eplerenone; Drug: Microcrystalline Cellulose NF (placebo)

Interventions

Eplerenone DRUG

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.

Eplerenone Then Placebo; Placebo Then Eplerenone

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.

Eplerenone Then Placebo; Placebo Then Eplerenone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Eye Center - The Oaks

Gainesville, Florida, 32605, United States

Location

Related Publications (1)

• Razavi SMS, Daneshvar R. Possible dose-dependent effect of eplerenone on intraocular pressure. Indian J Ophthalmol. 2023 Oct;71(10):3357-3360. doi: 10.4103/IJO.IJO_175_23.

  PMID: 37787235 BACKGROUND

MeSH Terms

Conditions

Ocular Hypertension

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ramin Daneshvar, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramin Daneshvar, M.D.

CONTACT

949-413-5593; rdaneshvar@ufl.edu

Alec Murphy, M.D.

CONTACT

770-687-3662; alecmurphy@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-masked, placebo-controlled crossover study. Participants will be randomized 1:1 to one of two treatment sequences: eplerenone 50 mg once daily for one week followed by placebo, or placebo followed by eplerenone. The two treatment periods will be separated by a two-week washout period. Each participant will receive both interventions and therefore serve as their own control.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

US (1)