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Not yet recruitingNCT07795762Updated Aug 31, 2026

Eplerenone and IOP in Healthy Adults

A Phase 1 interventional study of Eplerenone and Microcrystalline Cellulose NF (placebo) in Intraocular Pressure (IOP) and Healthy Adult, sponsored by University of Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by University of Florida · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 300 studies in Ocular Hypertension with a site in United States — 28 open to participants now, 35 under way, 6 of them phase 3. Ocular Hypertension · United States.

Planned enrollment
212th of 259
30 · median 106
Started
2026
with 14 others
Phase 1
19 of 300
2 open now
Primary completion
2027-02
later than 17 of 34 live
Registered
298th of 300
by date

Among the 300 studies in Ocular Hypertension with a site in United States, this one is the 212th largest by planned enrollment of the 259 interventional ones that give a count, is one of 15 that started in 2026, is one of 19 in phase 1, reaches primary completion later than 17 of the 34 other live ones, and was the 298th registered.

Ocular Hypertension

659 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

Browse Ocular Hypertension studies →

Open to participants now

28 of the 300 studies in Ocular Hypertension with a site in United States are open now. Recruiting first, the newest first:

23 more — sign in →

All 28 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 36 Ocular Hypertension studies recruiting now, 31 (86%) set no upper age limit and none (0%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Intraocular Pressure (IOP)
  • Healthy Adult

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Keywords

  • Eplerenone
  • Intraocular pressure
  • IOP
  • Mineralocorticoid receptor antagonist
  • Healthy volunteers
  • Healthy adults
  • Placebo-controlled
  • Ocular hypertension
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Use of topical or systemic
  • Renal disease or hyperkalemia
  • Concomitant use of strong 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study 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.

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

  • 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.

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

Interventions

  • 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.

  • DrugMicrocrystalline Cellulose NF (placebo)

    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.

06

What researchers measure

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.

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

07

Study locations

1 site
  • UF Health Eye Center - The Oaks
    Gainesville, Florida 32605, United States
    • Ramin Daneshvar, M.D. · Contactrdaneshvar@ufl.edu · 949-413-5593
    • Alec Murphy, M.D. · Contactalecmurphy@ufl.edu · 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
08

References and documents

Publications

  • 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. PubMed 37787235 ↗

Individual participant data

Plan to share: Undecided — The study team has not yet determined whether individual participant data will be shared with other researchers. A data-sharing plan may be developed following completion of the study and analysis of the study results.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Feb 2027, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 31, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07795762
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Ramin Daneshvar, M.D.
Contact
rdaneshvar@ufl.edu
949-413-5593
Alec Murphy, M.D.
Contact
alecmurphy@ufl.edu
770-687-3662
Ramin Daneshvar, M.D.
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Eplerenone

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