Eplerenone and IOP in Healthy Adults

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07795762
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Adult
  • Intraocular Pressure (IOP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Feb 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Eplerenone Then Placebo
    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.
  • Experimental: Placebo Then Eplerenone
    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.

Primary Outcome Measure

Change in Mean Intraocular Pressure With Eplerenone Compared With Placebo [ Time Frame: End of each 1-week treatment period (Day 7 and Day 28) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health Eye Center - The OaksGainesvilleFlorida32605
Ramin Daneshvar, M.D.
[email protected]
949-413-5593
Alec Murphy, M.D.
[email protected]
770-687-3662
Dylan McBee, M.D. (SUB_INVESTIGATOR)
Alec Murphy, M.D. (SUB_INVESTIGATOR)
Ramin Daneshvar, M.D. (PRINCIPAL_INVESTIGATOR)
Ian Smith, B.S. (SUB_INVESTIGATOR)
Logan Hibshman (SUB_INVESTIGATOR)

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By research site
UF Health Eye Center - The Oaks· Gainesville, FL

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