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This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost Intraocular Implant, high elution | Experimental | This implant will be surgically implanted and elute travoprost, a prostaglandin. |
|
| Travoprost Intraocular Implant, low elution | Experimental | This implant will be surgically implanted and elute travoprost, a prostaglandin. |
|
| Timolol Maleate Ophthalmic Solution, 0.5% | Active Comparator | Timolol, a beta blocker, will be dosed twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost Intraocular Implant, high elution | Drug | Surgical implant placed within the eye to elute travoprost. |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP (mmHg) Change From Baseline at Week 12 | Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline. | 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Severe Adverse Events | The number and percent of subjects with severe adverse events in the study eye | Post-op through Month 36 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Stephens, O.D. | Glaukos Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Berdahl, MD | Sioux Falls | South Dakota | 57108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38060092 | Derived | Berdahl JP, Sarkisian SR Jr, Ang RE, Doan LV, Kothe AC, Usner DW, Katz LJ, Navratil T; Travoprost Intraocular Implant Study Group. Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension. Drugs. 2024 Jan;84(1):83-97. doi: 10.1007/s40265-023-01973-7. Epub 2023 Dec 7. |
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The datasets generated during and/or analyzed during the current study are not publicly available at this time due to ongoing U.S. Food and Drug Administration review of a New Drug Application for the travoprost intraocular implant.
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Subjects underwent a washout from IOP-lowering medications after enrollment and prior to assignment to groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost Intraocular Implant, High Elution | This implant will be surgically implanted and elute travoprost, a prostaglandin. Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost. |
| FG001 | Travoprost Intraocular Implant, Low Elution | This implant will be surgically implanted and elute travoprost, a prostaglandin. Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost |
| FG002 | Timolol Maleate Ophthalmic Solution, 0.5% | Timolol, a beta blocker, will be dosed twice daily Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Each participant received treatment in only one eye
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| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost Intraocular Implant, High Elution | This implant will be surgically implanted and elute travoprost, a prostaglandin. Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost. |
| BG001 | Travoprost Intraocular Implant, Low Elution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | IOP (mmHg) Change From Baseline at Week 12 | Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline. | intent-to-treat population | Posted | Mean | Standard Error | mmHg | 12 weeks | eyes | eyes |
|
overall study period of 36 months
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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 | Travoprost Intraocular Implant, High Elution | This implant will be surgically implanted and elute travoprost, a prostaglandin. Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cataract | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Glaukos | 949-481-8076 | ldoan@glaukos.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 16, 2016 | Jul 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2022 | Jul 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Travoprost Intraocular Implant, low elution | Drug | Surgical implant placed within the eye to elute travoprost |
|
| Timolol Maleate Ophthalmic Solution, 0.5% | Drug | Instillation of one drop of timolol in the study eye twice daily |
|
| Lost to Follow-up |
|
| Death |
|
| Adverse Event |
|
| Other |
|
This implant will be surgically implanted and elute travoprost, a prostaglandin. Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost |
| BG002 | Timolol Maleate Ophthalmic Solution, 0.5% | Timolol, a beta blocker, will be dosed twice daily Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline IOP | Baseline IOP in mmHg was measured at 8AM by Goldmann tonometry after the appropriate washout from IOP-lowering medication(s) used at Screening | Mean | Standard Deviation | mmHg |
|
| OG002 | Timolol Maleate Ophthalmic Solution, 0.5% | Timolol, a beta blocker, will be dosed twice daily Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily |
|
|
| Other Pre-specified | Severe Adverse Events | The number and percent of subjects with severe adverse events in the study eye | study eyes | Posted | Count of Participants | Participants | Post-op through Month 36 |
|
|
|
| 0 |
| 51 |
| 4 |
| 51 |
| 28 |
| 51 |
| EG001 | Travoprost Intraocular Implant, Low Elution | This implant will be surgically implanted and elute travoprost, a prostaglandin. Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost | 2 | 54 | 9 | 54 | 22 | 54 |
| EG002 | Timolol Maleate Ophthalmic Solution, 0.5% | Timolol, a beta blocker, will be dosed twice daily Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily | 0 | 49 | 3 | 49 | 14 | 49 |
| arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| cardiac arrest | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| cardiac disorders | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| coronary artery disease | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| death | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| sepsis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| septic shock | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| cerebral infarction | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| myasthenia gravis | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| cholecystitis acute | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| haematoma | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| visual acuity reduced | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| vitreous detachment | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| blepharitis | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| conjunctival hemorrhage | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| eye pain | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| foreign body sensation in eyes | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| eye inflammation | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| intraocular pressure increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| drug hypersensitivity | Immune system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of data from this study.