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This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.
This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrus Microstent | Experimental | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye) |
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| iStent | Active Comparator | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrus Microstent | Device | Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. |
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| Measure | Description | Time Frame |
|---|---|---|
| Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Month 12: 8 am, 12 pm, 4 pm |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Month 12: 8 am, 12 pm, and 4 pm |
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Inclusion Criteria:
Exclusion Criteria:
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This reporting group includes all randomized patients (306).
Patients were screened and enrolled at 13 investigational sites outside of the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrus Microstent | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye) |
| FG001 | iStent | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2013 |
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| iStent Trabecular Micro Bypass | Device | Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. |
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| Cataract removal and intraocular lens (IOL) implantation | Procedure | Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects |
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| Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Month 12: 8 am, 12 pm, 4 pm |
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All randomized subjects, regardless of actual treatment received, procedure success, or compliance to protocol inclusion/exclusion criteria. [Intent-to-Treat (ITT)]
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrus Microstent | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye) |
| BG001 | iStent | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints. | Posted | Mean | Standard Deviation | mmHg | Month 12: 8 am, 12 pm, 4 pm | eyes | eyes |
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| Secondary | Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints. | Posted | Number | percentage of subjects | Month 12: 8 am, 12 pm, and 4 pm | eyes | eyes |
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| Secondary | Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints. | Posted | Number | percentage of subjects | Month 12: 8 am, 12 pm, 4 pm | eyes | eyes |
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| Post-Hoc | Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 24 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints. | Posted | Number | percentage of subjects | Month 24: 8 am, 12 pm, 4 pm | eyes | eyes |
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| Post-Hoc | Mean Change From Baseline in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 12: 8 am, 12 pm, 4 pm | eyes | eyes |
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| Post-Hoc | Mean Change From Baseline in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 24 | Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications. | Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 24: 8 am, 12 pm, 4 pm | eyes | eyes |
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Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrus Microstent | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (the study eye) | 4 | 154 | 2 | 154 | 24 | 154 |
| EG001 | iStent | Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (the study eye) | 3 | 152 | 8 | 152 | 16 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BCVA loss >/= 2 lines ETDRS >/= 3 months | Eye disorders | MedDRA (10.0) | Systematic Assessment | Post-operative event. Study eye. |
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| Epiretinal Membrane | Eye disorders | MedDRA (10.0) | Systematic Assessment | Post-operative event. Study eye. |
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| IOP Increase | Eye disorders | MedDRA (10.0) | Systematic Assessment | Post-operative event. Study eye. |
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| Uncontrolled Glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment | Post-operative event. Study eye. |
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| Wet Age-Related Macular Degeneration | Eye disorders | MedDRA (10.0) | Systematic Assessment | Post-operative event. Study eye. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOP Increase | Eye disorders | MedDRA (10.0) | Systematic Assessment | Post-operative Event |
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| Peripheral Anterior Synechia | Eye disorders | MedDRA (10.0) | Systematic Assessment | Post-operative Event |
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PI agrees that they shall not, without the Sponsor's prior written consent, independently publish, publicly disclose, present or discuss any results of or information pertaining to PI's activities conducted under this Agreement; unless the multi-center manuscript is not submitted for publication within one (1) year after completion of the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, CDMA Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Feb 19, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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