Benign Prostatic HyperplasiaPhase 4NCT03144596
The Effects of α-adrenergic Receptor Antagonists on Choroid and Pupil
A Phase 4 study testing Alfuzosin Hydrochloride 10 MG and Tamsulosin Hydrochloride 0.4 MG in people with Benign Prostatic Hyperplasia and Pupil Anomaly, run by Kocatepe University.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Pupil Anomaly, Choroid Disease
- What is being tested?
- Alfuzosin Hydrochloride 10 MG and Tamsulosin Hydrochloride 0.4 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2015to 19 Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Best corrected visual acuity (BCVA) ≥ 0.8
- Diagnosis of BPH and initiation of alfuzosin hydrochloride or tamsulosin hydrochloride treatments
- 45 years of age or older man
Who cannot join
- 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
About this study
Official title: The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases With Benign Prostatic Hyperplasia
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.
Read the detailed description
The local authorized clinical trials ethics committee approved the study and this study was performed following the principles of the Declaration of Helsinki. Detailed information was given to patients about clinical applications and tests, and signed informed consent forms were also obtained from all patients. 32 right eyes of 32 men with diagnosis of BPH initiated on AH (Xatral®) (10 mg/day) and 31 right eyes of 31 men with diagnosis of BPH initiated on TH (Flomax®) (0.4 mg/day) were included in this self-controlled prospective clinical trial. Urologists in the urology clinic made diagnosis of BPH, and 63 men diagnosis of BPH were directed towards eye clinic. AH or TH treatments were randomly recommended for previously untreated patients with newly diagnosis of BPH by urologists. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.
Ophthalmological examinations were performed in all cases. Choroidal thicknesses (CTs) were measured under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea, and they were recorded as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses. CTs were measured and recorded by using EDI-OCT imaging (Cirrus HD 4000, Carl Zeis Meditec, CA, USA). Mesopic, scotopic and photopic pupil diameter sizes were measured and recorded by using Scheimpflug/Placido photography-based topography system in the pupillometer mode (Sirius, Italy). CTs, scotopic, mesopic and photopic pupil diameter sizes were measured and recorded at baseline, 1st and 3rd months.
Data obtained from cases were encoded and they were transferred to the computer program. SPSS 20.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical evaluation. Data distribution was tested using Kolmogorov-Smirnov test. Baseline values and 1st, 3rd month values were compared by using the repeated measure of ANOVA in intra-group evaluation and independent samples t-test in inter-group evaluation, and the significance level of p-value was accepted as 0,05 (P ≤ 0, 05). Progressions were evaluated by using repeated measures analyses of variance-ANOVA (with the Bonferroni correction) and the correlation between parameters were evaluated by using bivariate (Pearson's) correlation analysis. Positive values and negative values were considered to be correlated in the same direction and opposite direction, respectively in correlation analysis. Correlation coefficient values r ≥ |± 0.3| were accepted as correlation; and the significance level of P value that was below 0,05 was evaluated as the significant correlation.
- Conditions
- Benign Prostatic Hyperplasia, Pupil Anomaly, Choroid Disease
- Being tested
- Alfuzosin Hydrochloride 10 MG, Tamsulosin Hydrochloride 0.4 MG
- Medical subject headings
- Prostatic Hyperplasia, Pupil Disorders, Choroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin Hydrochloride 10 MGDrug
Also called Xatral
Alfuzosin hydrochloride Tablet
Tamsulosin Hydrochloride 0.4 MGDrug
Also called Flomax
Tamsulosin Hydrochloride Tablet
| Study group | Role | What they receive |
|---|---|---|
| Alfuzosin Hydrochloride | Experimental | Alfuzosin hydrochloride 10 mg tablet by mouth, every 24 hours for 3 months Receives: Drug: Alfuzosin Hydrochloride 10 MG |
| Tamsulosin Hydrochloride | Active comparator | Tamsulosin hydrochloride 0.4 mg tablet by mouth, every 24 hours for 3 months Receives: Drug: Tamsulosin Hydrochloride 0.4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 month and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start29 Oct 2015
- Primary completion3 Feb 2016
- Study completion19 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, parallel-group clinical trial
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocatepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa Dogan, Asst. Prof., Study director, Afyon Kocatepe University Eye Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144596
- Sponsor's protocol ID
- 2011-KAEK-2 2015/342
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.
PubMed 6206240Yuan J, Liu Y, Yang Z, Qin X, Yang K, Mao C. The efficacy and safety of alpha-1 blockers for benign prostatic hyperplasia: an overview of 15 systematic reviews. Curr Med Res Opin. 2013 Mar;29(3):279-87. doi: 10.1185/03007995.2013.766594. Epub 2013 Jan 29.
PubMed 23323875McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
PubMed 21420124Filson CP, Hollingsworth JM, Clemens JQ, Wei JT. The efficacy and safety of combined therapy with alpha-blockers and anticholinergics for men with benign prostatic hyperplasia: a meta-analysis. J Urol. 2013 Dec;190(6):2153-60. doi: 10.1016/j.juro.2013.05.058. Epub 2013 May 30.
PubMed 23727412Osman NI, Chapple CR, Cruz F, Desgrandchamps F, Llorente C, Montorsi F. Silodosin : a new subtype selective alpha-1 antagonist for the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia. Expert Opin Pharmacother. 2012 Oct;13(14):2085-96. doi: 10.1517/14656566.2012.714368. Epub 2012 Aug 28.
PubMed 22924980Oelke M, Gericke A, Michel MC. Cardiovascular and ocular safety of alpha1-adrenoceptor antagonists in the treatment of male lower urinary tract symptoms. Expert Opin Drug Saf. 2014 Sep;13(9):1187-97. doi: 10.1517/14740338.2014.936376. Epub 2014 Jul 29.
PubMed 25073735Hollingsworth JM, Wilt TJ. Lower urinary tract symptoms in men. BMJ. 2014 Aug 14;349:g4474. doi: 10.1136/bmj.g4474.
PubMed 25125424Schwinn DA, Michelotti GA. alpha1-adrenergic receptors in the lower urinary tract and vascular bed: potential role for the alpha1d subtype in filling symptoms and effects of ageing on vascular expression. BJU Int. 2000 Apr;85 Suppl 2:6-11. doi: 10.1046/j.1464-410x.2000.00061.x. No abstract available.
PubMed 10781179Hatano A, Takahashi H, Tamaki M, Komeyama T, Koizumi T, Takeda M. Pharmacological evidence of distinct alpha 1-adrenoceptor subtypes mediating the contraction of human prostatic urethra and peripheral artery. Br J Pharmacol. 1994 Nov;113(3):723-8. doi: 10.1111/j.1476-5381.1994.tb17053.x.
PubMed 7858860de Mey C. alpha(1)-blockers for BPH: are there differences? Eur Urol. 1999;36 Suppl 3:52-63. doi: 10.1159/000052349.
PubMed 10559631Dunn CJ, Matheson A, Faulds DM. Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms. Drugs Aging. 2002;19(2):135-61. doi: 10.2165/00002512-200219020-00004.
PubMed 11950378Bird ST, Delaney JA, Brophy JM, Etminan M, Skeldon SC, Hartzema AG. Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology. BMJ. 2013 Nov 5;347:f6320. doi: 10.1136/bmj.f6320.
PubMed 24192967Chrischilles E, Rubenstein L, Chao J, Kreder KJ, Gilden D, Shah H. Initiation of nonselective alpha1-antagonist therapy and occurrence of hypotension-related adverse events among men with benign prostatic hyperplasia: a retrospective cohort study. Clin Ther. 2001 May;23(5):727-43. doi: 10.1016/s0149-2918(01)80022-9.
PubMed 11394731Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005 Apr;31(4):664-73. doi: 10.1016/j.jcrs.2005.02.027.
PubMed 15899440Abdel-Aziz S, Mamalis N. Intraoperative floppy iris syndrome. Curr Opin Ophthalmol. 2009 Jan;20(1):37-41. doi: 10.1097/ICU.0b013e32831bc0ad.
PubMed 19077827
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT03144596
- Acronym / sponsor ID
- 2011-KAEK-2 2015/342
- Conditions
- Benign Prostatic Hyperplasia, Pupil Anomaly, Choroid Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kocatepe UniversityUniversity, hospital or other
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 3 Feb 2016 (actual)
- Study completion
- 19 Nov 2016 (actual)
- First posted
- 9 May 2017 (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.
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.
Detailed description
The local authorized clinical trials ethics committee approved the study and this study was performed following the principles of the Declaration of Helsinki. Detailed information was given to patients about clinical applications and tests, and signed informed consent forms were also obtained from all patients. 32 right eyes of 32 men with diagnosis of BPH initiated on AH (Xatral®) (10 mg/day) and 31 right eyes of 31 men with diagnosis of BPH initiated on TH (Flomax®) (0.4 mg/day) were included in this self-controlled prospective clinical trial. Urologists in the urology clinic made diagnosis of BPH, and 63 men diagnosis of BPH were directed towards eye clinic. AH or TH treatments were randomly recommended for previously untreated patients with newly diagnosis of BPH by urologists. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.
Ophthalmological examinations were performed in all cases. Choroidal thicknesses (CTs) were measured under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea, and they were recorded as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses. CTs were measured and recorded by using EDI-OCT imaging (Cirrus HD 4000, Carl Zeis Meditec, CA, USA). Mesopic, scotopic and photopic pupil diameter sizes were measured and recorded by using Scheimpflug/Placido photography-based topography system in the pupillometer mode (Sirius, Italy). CTs, scotopic, mesopic and photopic pupil diameter sizes were measured and recorded at baseline, 1st and 3rd months.
Data obtained from cases were encoded and they were transferred to the computer program. SPSS 20.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical evaluation. Data distribution was tested using Kolmogorov-Smirnov test. Baseline values and 1st, 3rd month values were compared by using the repeated measure of ANOVA in intra-group evaluation and independent samples t-test in inter-group evaluation, and the significance level of p-value was accepted as 0,05 (P ≤ 0, 05). Progressions were evaluated by using repeated measures analyses of variance-ANOVA (with the Bonferroni correction) and the correlation between parameters were evaluated by using bivariate (Pearson's) correlation analysis. Positive values and negative values were considered to be correlated in the same direction and opposite direction, respectively in correlation analysis. Correlation coefficient values r ≥ |± 0.3| were accepted as correlation; and the significance level of P value that was below 0,05 was evaluated as the significant correlation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, parallel-group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Alfuzosin Hydrochloride | Experimental | Drug: Alfuzosin Hydrochloride 10 MGAlfuzosin hydrochloride 10 mg tablet by mouth, every 24 hours for 3 months |
| Tamsulosin Hydrochloride | Active comparator | Drug: Tamsulosin Hydrochloride 0.4 MGTamsulosin hydrochloride 0.4 mg tablet by mouth, every 24 hours for 3 months |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Best corrected visual acuity (BCVA) ≥ 0.8
- Diagnosis of BPH and initiation of alfuzosin hydrochloride or tamsulosin hydrochloride treatments
- 45 years of age or older man
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Alfuzosin Hydrochloride 10 MGAlso: XatralAlfuzosin hydrochloride Tablet | Drug | Alfuzosin Hydrochloride |
| Tamsulosin Hydrochloride 0.4 MGAlso: FlomaxTamsulosin Hydrochloride Tablet | Drug | Tamsulosin Hydrochloride |
Primary outcome
Change from baseline choroidal thicknesses at 3 months
Time frame: 1 month and 2 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.
Change from baseline pupil diameter sizes at 3 months
Time frame: 1 month and 2 months
Mesopic, scotopic and photopic pupil diameter sizes measurement at baseline, 1st and 3rd months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 6206240Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.
- Background: PubMed 23323875Yuan J, Liu Y, Yang Z, Qin X, Yang K, Mao C. The efficacy and safety of alpha-1 blockers for benign prostatic hyperplasia: an overview of 15 systematic reviews. Curr Med Res Opin. 2013 Mar;29(3):279-87. doi: 10.1185/03007995.2013.766594. Epub 2013 Jan 29.
- Background: PubMed 21420124McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
- Background: PubMed 23727412Filson CP, Hollingsworth JM, Clemens JQ, Wei JT. The efficacy and safety of combined therapy with alpha-blockers and anticholinergics for men with benign prostatic hyperplasia: a meta-analysis. J Urol. 2013 Dec;190(6):2153-60. doi: 10.1016/j.juro.2013.05.058. Epub 2013 May 30.
- Background: PubMed 22924980Osman NI, Chapple CR, Cruz F, Desgrandchamps F, Llorente C, Montorsi F. Silodosin : a new subtype selective alpha-1 antagonist for the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia. Expert Opin Pharmacother. 2012 Oct;13(14):2085-96. doi: 10.1517/14656566.2012.714368. Epub 2012 Aug 28.
- Background: PubMed 25073735Oelke M, Gericke A, Michel MC. Cardiovascular and ocular safety of alpha1-adrenoceptor antagonists in the treatment of male lower urinary tract symptoms. Expert Opin Drug Saf. 2014 Sep;13(9):1187-97. doi: 10.1517/14740338.2014.936376. Epub 2014 Jul 29.
- Background: PubMed 25125424Hollingsworth JM, Wilt TJ. Lower urinary tract symptoms in men. BMJ. 2014 Aug 14;349:g4474. doi: 10.1136/bmj.g4474.
- Background: PubMed 10781179Schwinn DA, Michelotti GA. alpha1-adrenergic receptors in the lower urinary tract and vascular bed: potential role for the alpha1d subtype in filling symptoms and effects of ageing on vascular expression. BJU Int. 2000 Apr;85 Suppl 2:6-11. doi: 10.1046/j.1464-410x.2000.00061.x. No abstract available.
- Background: PubMed 7858860Hatano A, Takahashi H, Tamaki M, Komeyama T, Koizumi T, Takeda M. Pharmacological evidence of distinct alpha 1-adrenoceptor subtypes mediating the contraction of human prostatic urethra and peripheral artery. Br J Pharmacol. 1994 Nov;113(3):723-8. doi: 10.1111/j.1476-5381.1994.tb17053.x.
- Background: PubMed 10559631de Mey C. alpha(1)-blockers for BPH: are there differences? Eur Urol. 1999;36 Suppl 3:52-63. doi: 10.1159/000052349.
- Background: PubMed 11950378Dunn CJ, Matheson A, Faulds DM. Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms. Drugs Aging. 2002;19(2):135-61. doi: 10.2165/00002512-200219020-00004.
- Background: PubMed 24192967Bird ST, Delaney JA, Brophy JM, Etminan M, Skeldon SC, Hartzema AG. Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology. BMJ. 2013 Nov 5;347:f6320. doi: 10.1136/bmj.f6320.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mustafa Dogan, Asst. Prof. study director
Afyon Kocatepe University Eye Clinics
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfuzosin Hydrochloride 10 MG and Tamsulosin Hydrochloride 0.4 MG in people with Benign Prostatic Hyperplasia and Pupil Anomaly, run by Kocatepe University.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline choroidal thicknesses at 3 months (time frame: 1 month and 2 months). The study lists 2 primary outcomes in all. 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 NCT03144596, which also lists 26 linked publications.
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 9 May 2017.