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NCT Number: NCT07795762

Eplerenone and IOP in Healthy Adults

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UF Health Eye Center - The Oaks

Gainesville, Florida, 32605, United States

Location contact

Alec Murphy, M.D.

CONTACT

[email protected]

770-687-3662

Alec Murphy, M.D.

SUB_INVESTIGATOR

Dylan McBee, M.D.

SUB_INVESTIGATOR

Ian Smith, B.S.

SUB_INVESTIGATOR

Logan Hibshman

SUB_INVESTIGATOR

Ramin Daneshvar, M.D.

CONTACT

[email protected]

949-413-5593

Ramin Daneshvar, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Mean Intraocular Pressure With Eplerenone Compared With Placebo

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alec Murphy, M.D.

CONTACT

[email protected]

770-687-3662

Ramin Daneshvar, M.D.

CONTACT

[email protected]

949-413-5593

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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