Intraocular Pressure (IOP), Healthy Adult
Conditions
Keywords
Eplerenone, Intraocular pressure, IOP, Mineralocorticoid receptor antagonist, Healthy volunteers, Healthy adults, Placebo-controlled, Ocular hypertension
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.
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.
Interventions
DRUGEplerenone
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.
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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Intraocular Pressure With Eplerenone Compared With Placebo | 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. |
Countries
United States
Contacts
CONTACTRamin Daneshvar, M.D.
CONTACTAlec Murphy, M.D.
PRINCIPAL_INVESTIGATORRamin Daneshvar, M.D.
University of Florida
Outcome results
None listed