Glaucoma, Open-AnglePhase 4NCT02388360
The Impact of Topical Prostaglandins on the Biomechanical Properties of the Cornea in Patients With Open Angle Glaucoma
A Phase 4 study testing topical prostaglandin analogs in people with Glaucoma, Open-Angle, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to determine the influence of topical prostaglandin analog (PGA) medication on corneal biomechanical properties in patients undergoing PGA treatment for open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- topical prostaglandin analogs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2013to 16 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with bilateral open angle glaucoma on monotherapy with topical PGA medication in both eyes
Who cannot join
- corneal disease (such as Fuchs' endothelial dystrophy or keratoconus)
- past history of corneal trauma or surgery (including refractive surgery) that may affect hysteresis measurements
- contact lens wearers
- uncontrolled glaucoma or advanced visual field (VF) damage (mean defect < -12.0 db)
- patients taking systemic prostaglandin medication, non-steroidal anti-inflammatory drugs, or undergoing hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Topical Prostaglandin Analogs on the Biomechanical Properties of the Cornea in Patients With Open Angle Glaucoma
The purpose of this study is to determine the influence of topical prostaglandin analog (PGA) medication on corneal biomechanical properties in patients undergoing PGA treatment for open-angle glaucoma.
Read the detailed description
Patients: Thirty five patients (seventy eyes) with bilateral open angle glaucoma on monotherapy with topical PGA medication in both eyes were recruited from the Montreal Glaucoma Institute, Montreal, QC, Canada. Informed consent was acquired from all participants. The research protocol of this study adhered to the tenets of the Declaration of Helsinki. It was approved by the Maisonneuve-Rosemont Hospital Ethics committee (Montreal, QC, Canada) and all patients signed a research consent form.
Study Procedures: Consenting patients undergoing topical PGA treatment in both eyes were asked to discontinue the PGA in their best eye and to continue the administration of PGA in the contralateral eye. All measurements were taken before PGA cessation (Visit 1) and repeated 6 weeks after cessation (Visit 2). Patients then restarted the application of PGA to the experimental eye and all measurements were repeated once more after an additional 6 weeks (Visit 3).
The best eye was selected based on less glaucoma damages. It was defined by the results of the Humphrey Visual Field (HFA, Carl Zeiss Meditec, Inc., Dublin, CA), Heidelberg Retinal Tomograph (HRT II, Heidelberg Engineering GmbH, Heidelberg, Germany) and Optical Coherence Tomography (CIRRUS HD-OCT, Carl Zeiss Meditec, Inc., Dublin, CA). The Humphrey Visual Field defines early glaucoma as a mean defect (MD) of -2.00 to -6.00 db, moderate glaucoma as a MD of -6.10 to -12.0 db and advanced as a MD less than -12.0 db. The Optical Coherence Tomography enables the identification of the better linear Cup/Disk ratio, Rim area, RNFL thickness and ganglion cells analysis between both of the patient's eyes. The lesser of the maximum IOP values recorded in each of the patient's eyes also contributed to the selection of the best eye.
Instruments: The Ocular Response Analyzer (ORA) (Reichert, INC, Depew, NY) was used to assess the biomechanical properties of the cornea. This instrument utilizes a dynamic bi-directional applanation process to measure the biomechanical properties of cornea and estimate IOP. A rapid air pulse applies force to the cornea and an advanced electro-optical system monitors corneal deformation. A precisely-metered collimated-air-pulse pushes the cornea inwards, past a flat state and into a slight concavity. Milliseconds after applanation, the air pump shuts off and the pressure gradually declines. As the pressure decreases, the cornea first passes through an applanated state before resuming its original curved structure. The applanation detection system monitors the corneal movement throughout the entire process. Two separate pressure values are derived from the INWARD and OUTWARD applanation events. The difference between these two pressure values is termed CH. This biomechanical property reflects corneal absorption and dissipation of the energy from an applied force. Derived from the measurement of CH is the Corneal resistance factor (CRF). CRF represents the cornea's ability to resist deformation in the presence of an external force.
Goldmann applanation tonometry (Haag-Streit AG, Koeniz, Switzerland) is still recognized as the gold standard for measuring IOP in glaucoma patients and it was performed in all patients at all visits. The ORA takes the CH and CRF measurements into account to generate the corneal-compensated intraocular pressure (IOPcc) value, which is mean to be less affected by corneal biomechanical properties than the Goldmann-IOP. The IOP bias is estimated as the difference between IOPcc and Goldmann-IOP (IOPcc - Goldmann IOP). A positive bias value indicates that the IOPcc is larger than the Goldmann-IOP, meaning that Goldman tonometry underestimated IOP in comparison to the IOPcc.
Four ORA measurements were taken per eye and the mean value was recorded for each parameter (CH, CRF and IOPcc). Central corneal thickness (CCT) was measured by ultrasound pachymetry (DGH Technology, INC, Exton, PA) and the average of three measurements was recorded. All study measurements were performed by the same trained observer (RM), with the same equipment and at the same time of day. All of the equipment needed for this research was calibrated prior to each use.
Statistical Analysis: The hypothesis of no effect regarding the discontinuation of PGA on the biomechanical properties was examined by a linear mixed-effect model using the nlme package in R. Random-effects were defined on two levels: the patient (level-1) and the eye within each patient (level-2). Those random-effects were added to the model to account for the intra-individual variance due to the repeated-measure design. Age was also included in the model as a covariate. Contrasts between the eyes and times were estimated using adjusted p-values to control for familywise error rate using multcomp package in R.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- topical prostaglandin analogs
- Keywords
- Prostaglandin analogs, Corneal biomechanics, Corneal Hysteresis, Glaucoma, Open-Angle
- 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.
topical prostaglandin analogsDrug
| Study group | Role | What they receive |
|---|---|---|
| topical prostaglandin analogs | Other | Not described Receives: Drug: topical prostaglandin analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Corneal Hysteresis (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA)
Measured: 12 weeks
Secondary outcomes (3)
The intraocular pressure (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from Goldmann tonometry
Measured: 12 weeks
The corneal thickness (in µm) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from pachymetry
Measured: 12 weeks
The Corneal Resistance Factor (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start6 May 2013
- Primary completion30 Jun 2016
- Study completion16 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Harasymowycz, Maisonneuve-Rosemont Hospital
- Investigators
- Paul Harasymowycz, Dr, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388360
- Sponsor's protocol ID
- MaisonneuveRH
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2014
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940Terai N, Raiskup F, Haustein M, Pillunat LE, Spoerl E. Identification of biomechanical properties of the cornea: the ocular response analyzer. Curr Eye Res. 2012 Jul;37(7):553-62. doi: 10.3109/02713683.2012.669007. Epub 2012 May 4.
PubMed 22559332Touboul D, Roberts C, Kerautret J, Garra C, Maurice-Tison S, Saubusse E, Colin J. Correlations between corneal hysteresis, intraocular pressure, and corneal central pachymetry. J Cataract Refract Surg. 2008 Apr;34(4):616-22. doi: 10.1016/j.jcrs.2007.11.051.
PubMed 18361984Ottino P, He J, Axelrad TW, Bazan HE. PAF-induced furin and MT1-MMP expression is independent of MMP-2 activation in corneal myofibroblasts. Invest Ophthalmol Vis Sci. 2005 Feb;46(2):487-96. doi: 10.1167/iovs.04-0852.
PubMed 15671273Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. doi: 10.1016/j.jcrs.2004.10.044.
PubMed 15721708Roberts C. The cornea is not a piece of plastic. J Refract Surg. 2000 Jul-Aug;16(4):407-13. doi: 10.3928/1081-597X-20000701-03. No abstract available.
PubMed 10939720Glass DH, Roberts CJ, Litsky AS, Weber PA. A viscoelastic biomechanical model of the cornea describing the effect of viscosity and elasticity on hysteresis. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3919-26. doi: 10.1167/iovs.07-1321. Epub 2008 Jun 6.
PubMed 18539936Roberts C. Biomechanics of the cornea and wavefront-guided laser refractive surgery. J Refract Surg. 2002 Sep-Oct;18(5):S589-92. doi: 10.3928/1081-597X-20020901-18.
PubMed 12361163Detry-Morel M, Jamart J, Hautenauven F, Pourjavan S. Comparison of the corneal biomechanical properties with the Ocular Response Analyzer(R) (ORA) in African and Caucasian normal subjects and patients with glaucoma. Acta Ophthalmol. 2012 Mar;90(2):e118-24. doi: 10.1111/j.1755-3768.2011.02274.x. Epub 2011 Oct 11.
PubMed 21989354Congdon NG, Broman AT, Bandeen-Roche K, Grover D, Quigley HA. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol. 2006 May;141(5):868-75. doi: 10.1016/j.ajo.2005.12.007. Epub 2006 Mar 9.
PubMed 16527231Agarwal DR, Ehrlich JR, Shimmyo M, Radcliffe NM. The relationship between corneal hysteresis and the magnitude of intraocular pressure reduction with topical prostaglandin therapy. Br J Ophthalmol. 2012 Feb;96(2):254-7. doi: 10.1136/bjo.2010.196899. Epub 2011 Mar 24.
PubMed 21436180Tsikripis P, Papaconstantinou D, Koutsandrea C, Apostolopoulos M, Georgalas I. The effect of prostaglandin analogs on the biomechanical properties and central thickness of the cornea of patients with open-angle glaucoma: a 3-year study on 108 eyes. Drug Des Devel Ther. 2013 Oct 4;7:1149-56. doi: 10.2147/DDDT.S50622. eCollection 2013.
PubMed 24115838Shah S, Laiquzzaman M, Cunliffe I, Mantry S. The use of the Reichert ocular response analyser to establish the relationship between ocular hysteresis, corneal resistance factor and central corneal thickness in normal eyes. Cont Lens Anterior Eye. 2006 Dec;29(5):257-62. doi: 10.1016/j.clae.2006.09.006. Epub 2006 Nov 7.
PubMed 17085066Detry-Morel M, Jamart J, Pourjavan S. Evaluation of corneal biomechanical properties with the Reichert Ocular Response Analyzer. Eur J Ophthalmol. 2011 Mar-Apr;21(2):138-48. doi: 10.5301/ejo.2010.2150.
PubMed 20853262Wells AP, Garway-Heath DF, Poostchi A, Wong T, Chan KC, Sachdev N. Corneal hysteresis but not corneal thickness correlates with optic nerve surface compliance in glaucoma patients. Invest Ophthalmol Vis Sci. 2008 Aug;49(8):3262-8. doi: 10.1167/iovs.07-1556. Epub 2008 Mar 3.
PubMed 18316697
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Topical Prostaglandin Analogs on the Biomechanical Properties of the Cornea in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02388360
- Acronym / sponsor ID
- MaisonneuveRH
- Conditions
- Glaucoma, Open-Angle
- Keywords
- Prostaglandin analogs, Corneal biomechanics, Corneal Hysteresis, Glaucoma, Open-Angle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 6 May 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
The purpose of this study is to determine the influence of topical prostaglandin analog (PGA) medication on corneal biomechanical properties in patients undergoing PGA treatment for open-angle glaucoma.
Detailed description
Patients: Thirty five patients (seventy eyes) with bilateral open angle glaucoma on monotherapy with topical PGA medication in both eyes were recruited from the Montreal Glaucoma Institute, Montreal, QC, Canada. Informed consent was acquired from all participants. The research protocol of this study adhered to the tenets of the Declaration of Helsinki. It was approved by the Maisonneuve-Rosemont Hospital Ethics committee (Montreal, QC, Canada) and all patients signed a research consent form.
Study Procedures: Consenting patients undergoing topical PGA treatment in both eyes were asked to discontinue the PGA in their best eye and to continue the administration of PGA in the contralateral eye. All measurements were taken before PGA cessation (Visit 1) and repeated 6 weeks after cessation (Visit 2). Patients then restarted the application of PGA to the experimental eye and all measurements were repeated once more after an additional 6 weeks (Visit 3).
The best eye was selected based on less glaucoma damages. It was defined by the results of the Humphrey Visual Field (HFA, Carl Zeiss Meditec, Inc., Dublin, CA), Heidelberg Retinal Tomograph (HRT II, Heidelberg Engineering GmbH, Heidelberg, Germany) and Optical Coherence Tomography (CIRRUS HD-OCT, Carl Zeiss Meditec, Inc., Dublin, CA). The Humphrey Visual Field defines early glaucoma as a mean defect (MD) of -2.00 to -6.00 db, moderate glaucoma as a MD of -6.10 to -12.0 db and advanced as a MD less than -12.0 db. The Optical Coherence Tomography enables the identification of the better linear Cup/Disk ratio, Rim area, RNFL thickness and ganglion cells analysis between both of the patient's eyes. The lesser of the maximum IOP values recorded in each of the patient's eyes also contributed to the selection of the best eye.
Instruments: The Ocular Response Analyzer (ORA) (Reichert, INC, Depew, NY) was used to assess the biomechanical properties of the cornea. This instrument utilizes a dynamic bi-directional applanation process to measure the biomechanical properties of cornea and estimate IOP. A rapid air pulse applies force to the cornea and an advanced electro-optical system monitors corneal deformation. A precisely-metered collimated-air-pulse pushes the cornea inwards, past a flat state and into a slight concavity. Milliseconds after applanation, the air pump shuts off and the pressure gradually declines. As the pressure decreases, the cornea first passes through an applanated state before resuming its original curved structure. The applanation detection system monitors the corneal movement throughout the entire process. Two separate pressure values are derived from the INWARD and OUTWARD applanation events. The difference between these two pressure values is termed CH. This biomechanical property reflects corneal absorption and dissipation of the energy from an applied force. Derived from the measurement of CH is the Corneal resistance factor (CRF). CRF represents the cornea's ability to resist deformation in the presence of an external force.
Goldmann applanation tonometry (Haag-Streit AG, Koeniz, Switzerland) is still recognized as the gold standard for measuring IOP in glaucoma patients and it was performed in all patients at all visits. The ORA takes the CH and CRF measurements into account to generate the corneal-compensated intraocular pressure (IOPcc) value, which is mean to be less affected by corneal biomechanical properties than the Goldmann-IOP. The IOP bias is estimated as the difference between IOPcc and Goldmann-IOP (IOPcc - Goldmann IOP). A positive bias value indicates that the IOPcc is larger than the Goldmann-IOP, meaning that Goldman tonometry underestimated IOP in comparison to the IOPcc.
Four ORA measurements were taken per eye and the mean value was recorded for each parameter (CH, CRF and IOPcc). Central corneal thickness (CCT) was measured by ultrasound pachymetry (DGH Technology, INC, Exton, PA) and the average of three measurements was recorded. All study measurements were performed by the same trained observer (RM), with the same equipment and at the same time of day. All of the equipment needed for this research was calibrated prior to each use.
Statistical Analysis: The hypothesis of no effect regarding the discontinuation of PGA on the biomechanical properties was examined by a linear mixed-effect model using the nlme package in R. Random-effects were defined on two levels: the patient (level-1) and the eye within each patient (level-2). Those random-effects were added to the model to account for the intra-individual variance due to the repeated-measure design. Age was also included in the model as a covariate. Contrasts between the eyes and times were estimated using adjusted p-values to control for familywise error rate using multcomp package in R.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| topical prostaglandin analogs | Other | Drug: topical prostaglandin analogs |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with bilateral open angle glaucoma on monotherapy with topical PGA medication in both eyes
Key exclusion criteria (5 listed)
- corneal disease (such as Fuchs' endothelial dystrophy or keratoconus)
- past history of corneal trauma or surgery (including refractive surgery) that may affect hysteresis measurements
- contact lens wearers
- uncontrolled glaucoma or advanced visual field (VF) damage (mean defect < -12.0 db)
- patients taking systemic prostaglandin medication, non-steroidal anti-inflammatory drugs, or undergoing hormone replacement therapy
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 |
|---|---|---|
| topical prostaglandin analogs | Drug | topical prostaglandin analogs |
Primary outcome
The Corneal Hysteresis (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA)
Time frame: 12 weeks
3 secondary outcomes
The intraocular pressure (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from Goldmann tonometry
Time frame: 12 weeks
The corneal thickness (in µm) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from pachymetry
Time frame: 12 weeks
The Corneal Resistance Factor (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA)
Time frame: 12 weeks
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 26 Feb 2021.
- Background: PubMed 16488940Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
- Background: PubMed 22559332Terai N, Raiskup F, Haustein M, Pillunat LE, Spoerl E. Identification of biomechanical properties of the cornea: the ocular response analyzer. Curr Eye Res. 2012 Jul;37(7):553-62. doi: 10.3109/02713683.2012.669007. Epub 2012 May 4.
- Background: PubMed 18361984Touboul D, Roberts C, Kerautret J, Garra C, Maurice-Tison S, Saubusse E, Colin J. Correlations between corneal hysteresis, intraocular pressure, and corneal central pachymetry. J Cataract Refract Surg. 2008 Apr;34(4):616-22. doi: 10.1016/j.jcrs.2007.11.051.
- Background: PubMed 15671273Ottino P, He J, Axelrad TW, Bazan HE. PAF-induced furin and MT1-MMP expression is independent of MMP-2 activation in corneal myofibroblasts. Invest Ophthalmol Vis Sci. 2005 Feb;46(2):487-96. doi: 10.1167/iovs.04-0852.
- Background: PubMed 15721708Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. doi: 10.1016/j.jcrs.2004.10.044.
- Background: PubMed 10939720Roberts C. The cornea is not a piece of plastic. J Refract Surg. 2000 Jul-Aug;16(4):407-13. doi: 10.3928/1081-597X-20000701-03. No abstract available.
- Background: PubMed 18539936Glass DH, Roberts CJ, Litsky AS, Weber PA. A viscoelastic biomechanical model of the cornea describing the effect of viscosity and elasticity on hysteresis. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3919-26. doi: 10.1167/iovs.07-1321. Epub 2008 Jun 6.
- Background: PubMed 12361163Roberts C. Biomechanics of the cornea and wavefront-guided laser refractive surgery. J Refract Surg. 2002 Sep-Oct;18(5):S589-92. doi: 10.3928/1081-597X-20020901-18.
- Background: PubMed 21989354Detry-Morel M, Jamart J, Hautenauven F, Pourjavan S. Comparison of the corneal biomechanical properties with the Ocular Response Analyzer(R) (ORA) in African and Caucasian normal subjects and patients with glaucoma. Acta Ophthalmol. 2012 Mar;90(2):e118-24. doi: 10.1111/j.1755-3768.2011.02274.x. Epub 2011 Oct 11.
- Background: PubMed 16527231Congdon NG, Broman AT, Bandeen-Roche K, Grover D, Quigley HA. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol. 2006 May;141(5):868-75. doi: 10.1016/j.ajo.2005.12.007. Epub 2006 Mar 9.
- Background: PubMed 21436180Agarwal DR, Ehrlich JR, Shimmyo M, Radcliffe NM. The relationship between corneal hysteresis and the magnitude of intraocular pressure reduction with topical prostaglandin therapy. Br J Ophthalmol. 2012 Feb;96(2):254-7. doi: 10.1136/bjo.2010.196899. Epub 2011 Mar 24.
- Background: PubMed 24115838Tsikripis P, Papaconstantinou D, Koutsandrea C, Apostolopoulos M, Georgalas I. The effect of prostaglandin analogs on the biomechanical properties and central thickness of the cornea of patients with open-angle glaucoma: a 3-year study on 108 eyes. Drug Des Devel Ther. 2013 Oct 4;7:1149-56. doi: 10.2147/DDDT.S50622. eCollection 2013.
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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.
Paul Harasymowycz, Dr principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing topical prostaglandin analogs in people with Glaucoma, Open-Angle, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 1 inclusion and 5 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The Corneal Hysteresis (in mmHg) difference in patient with PGAs and without PGAs based on the integrated analysis of the data collected from the Reichert Ocular Response Analyzer (ORA) (time frame: 12 weeks). 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 NCT02388360, which also lists 32 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 26 Feb 2021.