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The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.
Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrus Microstent | Experimental | Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrus Microstent | Device | Device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline | Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in MDIOP at Month 12 | Intraocular pressure was measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. A negative number represents a reduction from baseline. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Lead, CRD Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision | Fayetteville | Arkansas | 72704 | United States | ||
| Sacramento Eye Consultants |
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Of the 217 subjects who signed an informed consent, 117 were exited from the study prior to attempted implantation as screen failures. This reporting group includes all subjects for whom a Hydrus Microstent was implanted or implantation was attempted (100) (Safety Analysis Population).
Participants were recruited from 20 investigative sites located in the United States (16), Philippines (1), Spain (1), United Kingdom (1), and Colombia (1).
| ID | Title | Description |
|---|---|---|
| FG000 | Hydrus Microstent | Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted. |
| 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 | Aug 1, 2020 |
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| Ophthalmic surgery | Procedure | Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia |
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| Baseline, Month 12 |
| Sacramento |
| California |
| 95815 |
| United States |
| Eye Center of Northern Colorado | Fort Collins | Colorado | 80528 | United States |
| Ocala Eye | Ocala | Florida | 34474 | United States |
| Center for Sight | Venice | Florida | 34283 | United States |
| Stiles Eyecare | Overland Park | Kansas | 66213 | United States |
| Louisiana Eye and Laser Center | Alexandria | Louisiana | 71303 | United States |
| Washington University in St. Louis Ophthalmology | St Louis | Missouri | 63110 | United States |
| Scott & Christie and Associates | Cranberry Township | Pennsylvania | 16066 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| El Paso Eye Surgeons | El Paso | Texas | 79902 | United States |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | United States |
| Vale-Asche Russell Clinical Research Center | Houston | Texas | 77030 | United States |
| R and R Research, LLC | San Antonio | Texas | 78229 | United States |
| The Eye Centers of Racine and Kenosha | Kenosha | Wisconsin | 53142 | United States |
| Clínica Oftalmológica | Barranquilla | 080020 | Colombia |
| Asian Eye Institute | Makati City | 1200 | Philippines |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Manchester Royal Eye Hospital | Manchester | M13 9WL | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrus Microstent | Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted. |
| 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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| Age, Customized | Number | participants |
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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 | Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline | Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. | Effectiveness Population: All subjects who undergo the Hydrus implantation surgery and are not discontinued early from the study due to unrelated reasons such as death or relocation. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure. | Posted | Number | percentage of subjects | Baseline, Month 12 |
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| Secondary | Mean Change From Baseline in MDIOP at Month 12 | Intraocular pressure was measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. A negative number represents a reduction from baseline. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure. | Effectiveness Population: All subjects who undergo the Hydrus implantation surgery and are not discontinued early from the study due to unrelated reasons such as death or relocation. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure. | Posted | Mean | Standard Deviation | mmHG | Baseline, Month 12 | eyes | eyes |
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Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
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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 | Ocular Adverse Events | Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted. | 0 | 100 | 5 | 100 | 55 | 100 |
| EG001 | Non-Ocular Adverse Events | Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted. | 0 | 100 | 0 | 100 | 0 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated IOP | Eye disorders | Systematic Assessment |
| ||
| Elevated mean IOP | Eye disorders | Systematic Assessment | Equal or greater than 10 mmHg from baseline, greater than 1 month postoperatively |
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| Worsening of visual field | Eye disorders | Systematic Assessment | Mean deviation equal or greater than 3 dB confirmed by 2 repeat measurements |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AC cell or flare requiring change in steroid medication regimen | Eye disorders | Systematic Assessment |
| ||
| BCVA loss at greater than 1 month postoperative | Eye disorders | Systematic Assessment | BCVA loss defined as greater than or equal to 2 lines from baseline (ETDRS) |
| |
| BCVA loss at less than or equal to 1 month postoperative | Eye disorders | Systematic Assessment | BCVA loss defined as greater than or equal to 2 lines from baseline (ETDRS) |
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| Device obstruction | Eye disorders | Systematic Assessment |
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| Elevated mean IOP at greater than 1 month postoperative | Eye disorders | Systematic Assessment | Elevated mean IOP defined as IOP increase equal or greater than 10 mmHg from baseline |
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| Elevated mean IOP at less than or equal to 1 month postoperative | Eye disorders | Systematic Assessment | Elevated mean IOP defined as IOP increase equal or greater than 10 mmHg from baseline |
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| Hypotony (less than 6 mmHg) | Eye disorders | Systematic Assessment |
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| Surgical re-intervention in study eye | Eye disorders | Systematic Assessment | Not paracentesis within the 1 week visit |
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| Worsening of visual field | Eye disorders | Systematic Assessment | Mean deviation greater than or equal to 3 dB confirmed by 2 repeat measurements |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, CRD Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Dec 21, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 70 to less than 80 years |
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| 80 years and greater |
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| Mestizo |
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| White |
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| Refuses to Answer/Unknown |
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| eyes |
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