Intraocular Pressure (IOP)Phase 1NCT07795762
Eplerenone and IOP in Healthy Adults
A Phase 1 study testing Eplerenone in people with Intraocular Pressure (IOP) and Healthy Adult, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure (IOP), Healthy Adult
- What is being tested?
- Eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UF Health Eye Center - The Oaks
Gainesville, Florida, 32605
Ramin Daneshvar, M.D., 949-413-5593, rdaneshvar@ufl.edu
Alec Murphy, M.D., 770-687-3662, alecmurphy@ufl.edu
About this study
Official title: Effect of Short-Term Oral Eplerenone on Intraocular Pressure in Healthy Adult Volunteers: A Randomized, Double-Masked, Placebo-Controlled Crossover Study
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.
- Conditions
- Intraocular Pressure (IOP), Healthy Adult
- Being tested
- Eplerenone, Microcrystalline Cellulose NF (placebo)
- Keywords
- Eplerenone, Intraocular pressure, IOP, Mineralocorticoid receptor antagonist, Healthy volunteers, Healthy adults, Placebo-controlled, Ocular hypertension
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Eplerenone; Drug: Microcrystalline Cellulose NF (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of each 1-week treatment period (Day 7 and Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraocular Pressure (IOP)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramin Daneshvar, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795762
- Sponsor's protocol ID
- IRB202600169
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-Term Oral Eplerenone on Intraocular Pressure in Healthy Adult Volunteers: A Randomized, Double-Masked, Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT07795762
- Acronym / sponsor ID
- IRB202600169
- Conditions
- Intraocular Pressure (IOP), Healthy Adult
- Keywords
- Eplerenone, Intraocular pressure, IOP, Mineralocorticoid receptor antagonist, Healthy volunteers, Healthy adults, Placebo-controlled, Ocular hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Eplerenone Then Placebo | Experimental | Drug: Eplerenone, Drug: Microcrystalline Cellulose NF (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. |
| Placebo Then Eplerenone | Experimental | Drug: Eplerenone, Drug: Microcrystalline Cellulose NF (placebo)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplerenoneEplerenone 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. | Drug | Eplerenone Then Placebo, Placebo Then Eplerenone |
| Microcrystalline 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. | Drug | Eplerenone Then Placebo, Placebo Then Eplerenone |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 37787235Razavi 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramin Daneshvar, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eplerenone in people with Intraocular Pressure (IOP) and Healthy Adult, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramin Daneshvar, M.D. (949-413-5593, rdaneshvar@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07795762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.