Glaucoma, Open-AnglePhase 4NCT03966560
Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma
A Phase 4 study testing Brimonidine Tartrate, Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops and Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension in people with Glaucoma, Open-Angle, run by Afyon Kocatepe University Hospital.
Trial summary
Glaucoma is one of the leading causes of blindness worldwide that is a chronic public health problem. Unfortunately, glaucoma can be diagnosed when the disease reaches a certain level in today's conditions. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Brimonidine Tartrate, Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops and Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 2015
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the best corrected visual acuity (BCVA) of 0.6 and above
- Intraocular pressure being above 21 mmHg
- Detection of open-angle by gonioscopy
- Detection of glaucomatous optic disc pitting by fundus examination
- Visual field defect in perimetry (Carl Zeiss Meditec AG, Germany)
- The best corrected visual acuity (BCVA) of 0.8 and above
Who cannot join
- A secondary cause of glaucoma
- Angle-closure in gonioscopic examination
- Corneal opacity or cataract at the level that may affect imaging, vitreous pathology
- Intravitreal hemorrhage that may affect fundus appearance, retinal pathology
- Chorioretinopathy, optic neuropathy, optic disc pathology, spherical refractive error of 6D and above, cylindrical refraction error of 3D and above and systemic diseases which may affect ocular blood flow
- Presence of systemic disease that may affect choroid blood flow
- Ocular conditions that may affect test measurements
About this study
Official title: Choroidal Thickness and Its Correlations With Ocular Parameters in Cases With Primary Open-angle Glaucoma
Glaucoma is one of the leading causes of blindness worldwide that is a chronic public health problem. Unfortunately, glaucoma can be diagnosed when the disease reaches a certain level in today's conditions. The aim of this study was to investigate the diagnostic methods that can diagnose glaucoma before it reaches the advanced level and to identify pathophysiological processes. In this study, choroidal thickness was investigated in primary open-angle glaucoma cases and its correlations with OCT and multifocal ERG parameters were evaluated.
Read the detailed description
In this study, patients with primary open-angle glaucoma who have recently received a new diagnosis with healthy volunteers with age-matched groups were enrolled. All data from 49 glaucoma patients and 47 healthy volunteers were recorded and the study was completed. The study was carried out at the Afyon Kocatepe University Ophthalmology Department between January 2014 and April 2015. Routine ophthalmologic examinations of all participants were performed. Medical treatment was initiated on patients diagnosed with primary open-angle glaucoma. Intraocular pressures and visual acuities of all participants were recorded at baseline, at 1-month, at 3-month, and at 6-month. All participants underwent tests of multifocal electroretinography and the measurements of optic nerve head optical coherence tomography parameters and the choroidal thickness, at the same follow-ups. Visual acuities were measured by using the Snellen chart as the best corrected visual acuity. Intraocular pressures were measured by using applanation tonometry. Choroid thicknesses were also measured and recorded using EDI-OCT mode of optical coherence tomography device (Cirrus HD 4000, Carl Zeiss Meditec AG, Germany). Choroidal thicknesses were measured in three regions: fovea, 3mm nasal and temporal distances of the fovea. The mean of these three measurements was recorded as macular choroidal thickness. The same technician performed all multifocal electroretinography tests of the participants (Metrovision Monpack 3, Metrovision, France). Multifocal electroretinography tests were carried out from a distance of 33 cm using ERG-jet electrode, ground electrode, and a reference electrode. Electrical potential responses from 103 retina regions were recorded. Results were compared statistically and correlations were analyzed (SPSS 20.0, SPSS Inc. IL, USA).
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Brimonidine Tartrate, Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops, Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension, Travoprost and Timolol, Bimatoprost and Timolol
- Keywords
- choroidal thickness, multifocal electroretinography, optic nerve head, optical coherence tomography, primer open-angle glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine TartrateDrug
Also called Brimonidine Tartrate 0.15%
Brimonidine tartrate 0.15% 1 eye drop, every day for 6-months
Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye DropsDrug
Also called Dorzolamide and timolol fixed combination
Dorzolamide and timolol fixed combination 2 eye drops, every day for 6 months
Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic SuspensionDrug
Also called Brinzolamide and timolol fixed combination
Brinzolamide and timolol fixed combination 2 eye drops, every day for 6 months
Travoprost and TimololDrug
Also called Travoprost 0.004%/timolol 0.5% fixed combination
Travoprost and Timolol fixed combination 1 eye drop, every day for 6 months
Bimatoprost and TimololDrug
Also called Bimatoprost 0.03%/timolol 0.5% fixed combination
Bimatoprost and Timolol fixed combination 1 eye drop, every day for 6 months
LatanoprostDrug
Also called Latanoprost 0.005%
Latanoprost 0.005% 1 eye drop, every day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Primary open-angle glaucoma | Experimental | Participants over 40 years of age and diagnosed with primary open-angle glaucoma.
Medical treatment was initiated for the diagnosed participants. Receives: Drug: Brimonidine Tartrate; Drug: Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops; Drug: Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension; Drug: Travoprost and Timolol; Drug: Bimatoprost and Timolol; Drug: Latanoprost |
| Healthy | No intervention | Healthy volunteers who do not have systemic disease that may affect the choroidal thickness and have no ocular features that may affect test measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular choroidal thickness measure
Measuring macular choroidal thickness at baseline, at 1-month, at 3-month and at 6-month by using optical coherence tomography
Measured: Baseline, 1-month, 3-month, 6-month
Changes in multifocal electroretinography parameters (Amplitudes [nv/deg2] and impulse times [ms] of N1, N2 and P1 waves in Ring-1, Ring-2, Ring-3 and Ring-4)
Comparison of the mean multifocal electroretinography parameters (Amplitudes [nv/deg2] and impulse times [ms] of N1, N2 and P1 waves in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in amplitudes of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Comparison of the mean amplitudes of N1 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in amplitudes of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Comparison of the mean amplitudes of N2 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in amplitudes of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Comparison of the mean amplitudes of P1 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in impulse times of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
Comparison of the mean impulse times of N1 wave [ms] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in impulse times of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
Comparison of the mean impulse times of P1 wave [ms] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in P1/N1 ratio of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4
Comparison of the mean P1/N1 ratios of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in the mean optic nerve head optical coherence tomography parameters (Retinal nerve fiber layer thickness [micrometers], disc area [mm2], cup-to-disc ratios, cup volume [mm3], neuroretinal rim area [mm2])
Measuring optic nerve head optical coherence tomography parameters (Retinal nerve fiber layer thickness [micrometers], disc area [mm2], cup-to-disc ratios, cup volume [mm3], neuroretinal rim area [mm2]) at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in the mean neuroretinal rim area [mm2])
Measuring neuroretinal rim area [mm2] at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in the mean cup volume [mm3]
Measuring cup volume [mm3] at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in the mean cup-to-disc ratios
Measuring cup-to-disc ratios at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in the mean disc area [mm2]
Measuring disc area [mm2] at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Changes in the mean retinal nerve fiber layer thickness [micrometers]
Measuring retinal nerve fiber layer thicknesses [micrometers] at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Secondary outcomes (3)
Best-corrected visual acuity measure
Comparison of the mean best-corrected visual acuities at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Intraocular pressure measure
Measuring intraocular pressure at 1-month, at 3-month and at 6-month
Measured: Baseline, 1-month, 3-month, 6-month
Correlations between choroidal thickness and other parameters
Analyze correlations between changes of choroidal thicknesses and changes of other parameters during the study.
Measured: Baseline, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study startJan 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyon Kocatepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966560
- Sponsor's protocol ID
- KAEK-2014/04-74
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Thickness and Its Correlations With Ocular Parameters in Cases With Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT03966560
- Acronym / sponsor ID
- KAEK-2014/04-74
- Conditions
- Glaucoma, Open-Angle
- Keywords
- choroidal thickness, multifocal electroretinography, optic nerve head, optical coherence tomography, primer open-angle glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Afyon Kocatepe University HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 May 2019 (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.
Glaucoma is one of the leading causes of blindness worldwide that is a chronic public health problem. Unfortunately, glaucoma can be diagnosed when the disease reaches a certain level in today's conditions. The aim of this study was to investigate the diagnostic methods that can diagnose glaucoma before it reaches the advanced level and to identify pathophysiological processes. In this study, choroidal thickness was investigated in primary open-angle glaucoma cases and its correlations with OCT and multifocal ERG parameters were evaluated.
Detailed description
In this study, patients with primary open-angle glaucoma who have recently received a new diagnosis with healthy volunteers with age-matched groups were enrolled. All data from 49 glaucoma patients and 47 healthy volunteers were recorded and the study was completed. The study was carried out at the Afyon Kocatepe University Ophthalmology Department between January 2014 and April 2015. Routine ophthalmologic examinations of all participants were performed. Medical treatment was initiated on patients diagnosed with primary open-angle glaucoma. Intraocular pressures and visual acuities of all participants were recorded at baseline, at 1-month, at 3-month, and at 6-month. All participants underwent tests of multifocal electroretinography and the measurements of optic nerve head optical coherence tomography parameters and the choroidal thickness, at the same follow-ups. Visual acuities were measured by using the Snellen chart as the best corrected visual acuity. Intraocular pressures were measured by using applanation tonometry. Choroid thicknesses were also measured and recorded using EDI-OCT mode of optical coherence tomography device (Cirrus HD 4000, Carl Zeiss Meditec AG, Germany). Choroidal thicknesses were measured in three regions: fovea, 3mm nasal and temporal distances of the fovea. The mean of these three measurements was recorded as macular choroidal thickness. The same technician performed all multifocal electroretinography tests of the participants (Metrovision Monpack 3, Metrovision, France). Multifocal electroretinography tests were carried out from a distance of 33 cm using ERG-jet electrode, ground electrode, and a reference electrode. Electrical potential responses from 103 retina regions were recorded. Results were compared statistically and correlations were analyzed (SPSS 20.0, SPSS Inc. IL, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Primary open-angle glaucoma | Experimental | Drug: Brimonidine Tartrate, Drug: Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops, Drug: Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension, Drug: Travoprost and Timolol, Drug: Bimatoprost and Timolol, Drug: LatanoprostParticipants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants. |
| Healthy | No intervention | –Healthy volunteers who do not have systemic disease that may affect the choroidal thickness and have no ocular features that may affect test measurements. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the best corrected visual acuity (BCVA) of 0.6 and above
- Intraocular pressure being above 21 mmHg
- Detection of open-angle by gonioscopy
- Detection of glaucomatous optic disc pitting by fundus examination
- Visual field defect in perimetry (Carl Zeiss Meditec AG, Germany)
Key exclusion criteria (7 listed)
- A secondary cause of glaucoma
- Angle-closure in gonioscopic examination
- Corneal opacity or cataract at the level that may affect imaging, vitreous pathology
- Intravitreal hemorrhage that may affect fundus appearance, retinal pathology
- Chorioretinopathy, optic neuropathy, optic disc pathology, spherical refractive error of 6D and above, cylindrical refraction error of 3D and above and systemic diseases which may affect ocular blood flow
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 |
|---|---|---|
| Brimonidine TartrateAlso: Brimonidine Tartrate 0.15%Brimonidine tartrate 0.15% 1 eye drop, every day for 6-months | Drug | Primary open-angle glaucoma |
| Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye DropsAlso: Dorzolamide and timolol fixed combinationDorzolamide and timolol fixed combination 2 eye drops, every day for 6 months | Drug | Primary open-angle glaucoma |
| Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic SuspensionAlso: Brinzolamide and timolol fixed combinationBrinzolamide and timolol fixed combination 2 eye drops, every day for 6 months | Drug | Primary open-angle glaucoma |
| Travoprost and TimololAlso: Travoprost 0.004%/timolol 0.5% fixed combinationTravoprost and Timolol fixed combination 1 eye drop, every day for 6 months | Drug | Primary open-angle glaucoma |
| Bimatoprost and TimololAlso: Bimatoprost 0.03%/timolol 0.5% fixed combinationBimatoprost and Timolol fixed combination 1 eye drop, every day for 6 months | Drug | Primary open-angle glaucoma |
| LatanoprostAlso: Latanoprost 0.005%Latanoprost 0.005% 1 eye drop, every day for 6 months | Drug | Primary open-angle glaucoma |
Primary outcome
Macular choroidal thickness measure
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring macular choroidal thickness at baseline, at 1-month, at 3-month and at 6-month by using optical coherence tomography
Changes in multifocal electroretinography parameters (Amplitudes [nv/deg2] and impulse times [ms] of N1, N2 and P1 waves in Ring-1, Ring-2, Ring-3 and Ring-4)
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean multifocal electroretinography parameters (Amplitudes [nv/deg2] and impulse times [ms] of N1, N2 and P1 waves in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Changes in amplitudes of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean amplitudes of N1 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Changes in amplitudes of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean amplitudes of N2 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Changes in amplitudes of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean amplitudes of P1 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Changes in impulse times of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean impulse times of N1 wave [ms] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Changes in impulse times of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean impulse times of P1 wave [ms] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Changes in P1/N1 ratio of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean P1/N1 ratios of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Changes in the mean optic nerve head optical coherence tomography parameters (Retinal nerve fiber layer thickness [micrometers], disc area [mm2], cup-to-disc ratios, cup volume [mm3], neuroretinal rim area [mm2])
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring optic nerve head optical coherence tomography parameters (Retinal nerve fiber layer thickness [micrometers], disc area [mm2], cup-to-disc ratios, cup volume [mm3], neuroretinal rim area [mm2]) at 1-month, at 3-month and at 6-month
Changes in the mean neuroretinal rim area [mm2])
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring neuroretinal rim area [mm2] at 1-month, at 3-month and at 6-month
Changes in the mean cup volume [mm3]
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring cup volume [mm3] at 1-month, at 3-month and at 6-month
Changes in the mean cup-to-disc ratios
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring cup-to-disc ratios at 1-month, at 3-month and at 6-month
Changes in the mean disc area [mm2]
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring disc area [mm2] at 1-month, at 3-month and at 6-month
Changes in the mean retinal nerve fiber layer thickness [micrometers]
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring retinal nerve fiber layer thicknesses [micrometers] at 1-month, at 3-month and at 6-month
3 secondary outcomes
Best-corrected visual acuity measure
Time frame: Baseline, 1-month, 3-month, 6-month
Intraocular pressure measure
Time frame: Baseline, 1-month, 3-month, 6-month
Correlations between choroidal thickness and other parameters
Time frame: Baseline, 6-month
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 29 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brimonidine Tartrate, Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops and Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension in people with Glaucoma, Open-Angle, run by Afyon Kocatepe University Hospital.
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 6 inclusion and 7 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 29 May 2019. 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?
Macular choroidal thickness measure (time frame: Baseline, 1-month, 3-month, 6-month). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2019; AzTrials last refreshed its copy on 30 Oct 2026.