UF Health Eye Center - The Oaks
Gainesville, Florida, 32605, United States
NCT Number: NCT07795762
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Phase 1
Gainesville, Florida, 32605, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Trial opening soon.
Get NotifiedUniversity of Florida
Other
Effect of Short-Term Oral Eplerenone on Intraocular Pressure in Healthy Adult Volunteers: A Randomized, Double-Masked, Placebo-Controlled Crossover Study
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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