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Phase III study to compare the safety and efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR 063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant Group 1 | Experimental | G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. |
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| Implant Group 2 | Experimental | G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. |
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| Control Group | Active Comparator | Sham surgery + active-comparator eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G2-TR intraocular implant containing travoprost | Combination Product | Provided in Arm/Group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative | Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative | Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit | 12 months |
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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 |
|---|---|---|---|---|---|---|
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39240530 | Derived | Singh IP, Berdahl JP, Sarkisian SR Jr, Voskanyan LA, Ang RE, Doan LV, Applegate D, Shen Y, Katz LJ, Kothe AC, Navratil T. Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials. Drugs. 2024 Oct;84(10):1299-1311. doi: 10.1007/s40265-024-02074-9. Epub 2024 Sep 6. | |
| 38985408 |
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subjects required to undergo washout of prior IOP-lowering medication(s) if applicable and to meet inclusion/exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Implant Group 1 | G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions. |
| FG001 | Implant Group 2 |
| 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 | Yes | No | No | Study Protocol | Jun 6, 2022 | Jul 20, 2023 |
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| Sham surgery + active-comparator eye drops | Drug | Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%). |
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| Bacharach J, Doan LV, Stephens KG, Usner DW, Kothe AC, Katz LJ, Navratil T. Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2024 Sep;13(9):2357-2367. doi: 10.1007/s40123-024-00992-1. Epub 2024 Jul 10. |
| 38345710 | Derived | Sarkisian SR, Ang RE, Lee AM, Berdahl JP, Heersink SB, Burden JH, Doan LV, Stephens KG, Applegate D, Kothe AC, Usner DW, Katz LJ, Navratil T. Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial. Ophthalmol Ther. 2024 Apr;13(4):995-1014. doi: 10.1007/s40123-024-00898-y. Epub 2024 Feb 12. |
| 35076329 | Derived | Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146. |
G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions. |
| FG002 | Control Group | Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%). |
| Month 3 |
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| Month 12 |
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| COMPLETED |
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| NOT COMPLETED |
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Intent to treat analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Implant Group 1 | G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions. |
| BG001 | Implant Group 2 | G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions. |
| BG002 | Control Group | Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%). |
| BG003 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Mean Diurnal IOP | Average of the intraocular pressure at the 8AM, 10AM and 4PM timepoints following washout from prior IOP-lowering medication(s), if applicable | Mean | Standard Deviation | mmHg |
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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 | Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative | Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP. | intent to treatment analysis set which includes all randomized subjects with analyses performed according to original treatment assignment, regardless of actual treatment received | Posted | Least Squares Mean | Standard Error | mmHg | 3 months | study eyes | study eyes |
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| Secondary | Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative | Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit | Not Posted | Jun 2025 | 12 months | Participants |
12 months post-operative
The safety analysis set includes all subjects who were randomized & received >= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized & not treated, & 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.
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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 | Implant Group 1 | G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions. | 2 | 200 | 5 | 200 | 16 | 200 |
| EG001 | Implant Group 2 | G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions. | 0 | 195 | 6 | 195 | 21 | 195 |
| EG002 | Control Group | Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%). | 4 | 194 | 7 | 194 | 4 | 194 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Combined adverse events in Cardiac Disorders SOC | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment | All AEs in SOC combined to prevent unmasking in this ongoing double-masked trial |
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| Combined adverse events in Musculoskeletal and Connective Tissue Disorders SOC | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment | All AEs in SOC combined to prevent unmasking in this ongoing double-masked trial |
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| Combined adverse events in Infections and Infestations SOC | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment | All AEs in SOC combined to prevent unmasking in this ongoing double-masked trial |
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| Combined adverse events in Psychiatric Disorders SOC | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment | All AEs in SOC combined to prevent unmasking in this ongoing double-masked trial |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| iritis | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| intraocular pressure increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
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This is an ongoing double-masked trial. Therefore, limited adverse event data are presented in order to prevent unmasking.
Sponsor reserves the right of prior review of any publication or presentation of data from this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Glaukos | 949-481-8076 | ldoan@glaukos.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2022 | Jul 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Philippines |
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| Week 6, 8AM |
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| Week 6, 10AM |
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| Month 3, 8AM |
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| Month 3, 10AM |
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| Day 10, 10AM Difference between Implant Group 2 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -1.24 | 2-Sided | 95 | -1.92 | -0.56 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol |
| Week 6, 8AM Difference between Implant Group 2 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -0.18 | 2-Sided | 95 | -0.86 | 0.51 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol |
| Week 6, 10AM Difference between Implant Group 2 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -0.77 | 2-Sided | 95 | -1.43 | -0.11 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol |
| Month 3, 8AM Difference between Implant Group 2 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | 0.10 | 2-Sided | 95 | -0.63 | 0.82 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol |
| Month 3, 10AM Difference between Implant Group 2 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -0.16 | 2-Sided | 95 | -0.89 | 0.57 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol |
| Day 10, 8AM Difference between Implant Group 1 vs. Timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -0.72 | 2-Sided | 95 | -1.38 | -0.06 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol |
| Day 10, 10AM Difference between Implant Group 1 vs. Timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -1.15 | 2-Sided | 95 | -1.83 | -0.48 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol |
| Week 6, 8AM Difference between Implant Group 1 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -0.25 | 2-Sided | 95 | -0.93 | 0.43 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol |
| Week 6, 10AM Difference between Implant Group 1 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -0.74 | 2-Sided | 95 | -1.40 | -0.08 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol |
| Month 3, 8AM Difference between Implant Group 1 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | 0.10 | 2-Sided | 95 | -0.62 | 0.83 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol |
| Month 3, 10AM Difference between Implant Group 1 and timolol | Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol | Mean Difference (Final Values) | -0.04 | 2-Sided | 95 | -0.77 | 0.69 | Non-Inferiority | criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol |