The Effects of α-adrenergic Receptor Antagonists on Choroid and Pupil

NCT03144596 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2011-KAEK-2 2015/342
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

It was aimed to evaluate and investigate the effects of tamsulosin hydrochloride, has preferential selectivity for the α1A receptor in the prostat versus the α1B receptor in the blood vessels, and alfuzosin hydrochloride on choroidal thickness (CT), pupil diameter sizes evaluated by using enhanced depth imaging spectral-domain optical coherence tomography (EDI-OCT) and scheimpflug/placido photography-based topoghraphy system in this study. 63 men patients with newly diagnosis of benign prostatic hyperplasia were randomly assigned to either alfuzosin hydrochloride or to tamsulosin hydrochloride groups in this prospective, randomized, parallel-group clinical trial. Enhanced depth imaging spectral-domain optical coherence tomography, pupillography were obtained at baseline, 1st and 3rd month, and choroidal thicknesses and pupil diameter sizes were compared between the 2 groups.

Conditions

Benign Prostatic Hyperplasia; Pupil Anomaly; Choroid Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline choroidal thicknesses at 3 months

  Choroidal thicknesses (CTs) measurement under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea at baseline, 1st and 3rd month, and recording as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses.

  1 month and 2 months

• Change from baseline pupil diameter sizes at 3 months

  Mesopic, scotopic and photopic pupil diameter sizes measurement at baseline, 1st and 3rd months

  1 month and 2 months

Study Arms (2)

Alfuzosin Hydrochloride

EXPERIMENTAL

Alfuzosin hydrochloride 10 mg tablet by mouth, every 24 hours for 3 months

Drug: Alfuzosin Hydrochloride 10 MG

Tamsulosin Hydrochloride

ACTIVE COMPARATOR

Tamsulosin hydrochloride 0.4 mg tablet by mouth, every 24 hours for 3 months

Drug: Tamsulosin Hydrochloride 0.4 MG

Interventions

Alfuzosin Hydrochloride 10 MG DRUG

Alfuzosin hydrochloride Tablet

Also known as: Xatral

Alfuzosin Hydrochloride

Tamsulosin Hydrochloride 0.4 MG DRUG

Tamsulosin Hydrochloride Tablet

Also known as: Flomax

Tamsulosin Hydrochloride

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Best corrected visual acuity (BCVA) ≥ 0.8
• Diagnosis of BPH and initiation of alfuzosin hydrochloride or tamsulosin hydrochloride treatments
• years of age or older man

You may not qualify if:

• Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)
• Corneal scarring or cataract that prevents appearance of the fundus
• Formation of macular or peripheral retinal pathologies or choroidopathy
• Optic nerve pathologies such as optic neuropathy
• Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
• Systemic diseases that may affect choroidal blood flow

Sponsors & Collaborators

• Kocatepe University: lead

Related Publications (26)

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MeSH Terms

Conditions

Prostatic Hyperplasia; Pupil Disorders; Choroid Diseases

Interventions

alfuzosin; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uveal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Mustafa Dogan, Asst. Prof.

  Afyon Kocatepe University Eye Clinics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, parallel-group clinical trial

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 9, 2017
• Study Start: October 29, 2015
• Primary Completion: February 3, 2016
• Study Completion: November 19, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05