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Do common prostate drugs change the eye? a trial investigates

NCT ID NCT07743060

Knowledge-focused Sponsor: Mohsen Pourazizi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study compares two common prostate medications, tamsulosin and silodosin, to see how they affect pupil size and the thickness of a layer at the back of the eye called the choroid. Men aged 50 and older with benign prostatic hyperplasia (BPH) who have not used these drugs before will take one of the two medications daily for three months. Researchers will measure pupil size under different lighting conditions and choroidal thickness before and after treatment. The goal is to understand if these drugs cause eye changes that could increase risks during cataract surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tamsulosin 0.4 mg daily or silodosin 8 mg daily
What this could lead to
If this trial shows one drug has less effect on the eye, it could help guide safer choices for men with BPH who may need cataract surgery later.
What could go wrong
This is a small, early-stage comparison. The results may not apply to all patients, and the study only looks at eye changes, not long-term safety or cataract surgery outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men ≥ 50 years of age with a definitive diagnosis of BPH by a collaborating urologist. * Patients with moderate symptoms based onthe International Prostate Symptom Score (IPSS): score 8 to 19 * No prior use of any alpha-blocker (tamsulosin, silodosin, doxazosin, etc.) * Vision adequate for imaging * Consent to participate in the study * No history of any intraocular surgery; no active or structural ocular disease affecting the pupil/iris, such as glaucoma, uveitis, pseudoexfoliation syndrome, pigment dispersion syndrome. * No use of pupil-affecting eye drops within the past 2 weeks Exclusion Criteria: * High myopia (SE ≤ -6.00 D) or axial length \> 26.5 mm, in order to control for its effect on choroidal thickness * History of trauma or injury to the iris * Insufficient image quality during assessments * Patient unwilling to continue participation in the study * Occurrence of unwanted systemic adverse effects during the study * Improper medication adherence during the study * Diabetes * Hypertension

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia iris disorder optic choroid disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia Choroid Iris disease Silodosin Tamsulosin Tomography, optical coherence

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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