A Phase 3 interventional study of G2-TR intraocular implant containing travoprost and Sham surgery + active-comparator eye drops in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Glaukos Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Glaukos Corporation · Phase 3, Interventional, and Treatment
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.
649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.
This study's enrollment of 560 is above the median of 120 across 510 interventional studies indexed under Ocular Hypertension.
Browse Ocular Hypertension studies →Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Combination Product: G2-TR intraocular implant containing travoprost
G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Combination Product: G2-TR intraocular implant containing travoprost
Sham surgery + active-comparator eye drops
Drug: Sham surgery + active-comparator eye drops
Provided in Arm/Group descriptions
Also known as: Implant Group
Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Also known as: Control Group
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.
Time frame: 3 Months
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
Time frame: 12 Months
| Milestone | Implant Group 1 | Implant Group 2 | Control Group |
|---|---|---|---|
| Started | 185 | 183 | 192 |
| Month 3 | 182 | 182 | 190 |
| Month 12 | 176 | 180 | 183 |
| Completed | 0 | 0 | 0 |
| Not completed | 185 | 183 | 192 |
| Withdrew: Withdrawal by subject | 4 | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 |
| Withdrew: Death | 1 | 1 | 2 |
| Withdrew: Adverse event | 0 | 0 | 3 |
| Withdrew: Explanted | 2 | 1 | 0 |
| Withdrew: Ongoing in study | 176 | 180 | 183 |
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.
| mmHg | Implant Group 1 | Implant Group 2 | Control Group |
|---|---|---|---|
| Day 10, 8AM | -8.26 ± 0.27 | -8.40 ± 0.27 | -7.16 ± 0.26 |
| Day 10, 10AM | -8.20 ± 0.25 | -8.28 ± 0.25 | -7.08 ± 0.24 |
| Week 6, 8AM | -6.83 ± 0.26 | -7.20 ± 0.26 | -7.17 ± 0.26 |
| Week 6, 10AM | -6.92 ± 0.25 | -6.83 ± 0.25 | -7.15 ± 0.25 |
| Month 3, 8AM | -6.29 ± 0.28 | -6.66 ± 0.27 | -6.82 ± 0.27 |
| Month 3, 10AM | -6.21 ± 0.27 | -6.79 ± 0.27 | -6.76 ± 0.26 |
Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit
Results for this outcome have not been posted.
Collected over 12 months post-operative. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implant Group 1 | 1/185 (0.5%) | 6/185 (3.2%) | 20/185 (10.8%) |
| Implant Group 2 | 1/183 (0.5%) | 4/183 (2.2%) | 23/183 (12.6%) |
| Control Group | 2/192 (1%) | 2/192 (1%) | 7/192 (3.6%) |
| Event | Implant Group 1 | Implant Group 2 | Control Group |
|---|---|---|---|
| Combined adverse events in Cardiac Disorders SOCCardiac disorders | 5/185 | 1/183 | 1/192 |
| Combined adverse events in Neoplasms SOCNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/185 | 3/183 | 1/192 |
| Event | Implant Group 1 | Implant Group 2 | Control Group |
|---|---|---|---|
| intraocular pressure increasedInvestigations | 12/185 | 13/183 | 6/192 |
| IritisEye disorders | 8/185 | 10/183 | 1/192 |
intent to treat analysis set
| Age, Categorical(Participants) | Implant Group 1 | Implant Group 2 | Control Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 92 | 100 | 93 | 285 |
| >=65 years | 93 | 83 | 99 | 275 |
| Age, Continuous(years) | Implant Group 1 | Implant Group 2 | Control Group | Total |
|---|---|---|---|---|
| Mean | 63.1 ± 11.8 | 61.9 ± 12.8 | 63.9 ± 12.1 | 63.0 ± 12.2 |
| Sex: Female, Male(Participants) | Implant Group 1 | Implant Group 2 | Control Group | Total |
|---|---|---|---|---|
| Female | 88 | 88 | 105 | 281 |
| Male | 97 | 95 | 87 | 279 |
| Race (NIH/OMB)(Participants) | Implant Group 1 | Implant Group 2 | Control Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 2 | 2 | 7 |
| Asian | 1 | 2 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 26 | 22 | 20 | 68 |
| White | 150 | 155 | 162 | 467 |
| More than one race | 1 | 0 | 1 | 2 |
| Unknown or Not Reported | 4 | 2 | 5 | 11 |
| Region of Enrollment(participants) | Implant Group 1 | Implant Group 2 | Control Group | Total |
|---|---|---|---|---|
| United States | 168 | 167 | 175 | 510 |
| Armenia | 17 | 16 | 17 | 50 |
| Baseline Mean Diurnal IOP(mmHg) | Implant Group 1 | Implant Group 2 | Control Group | Total |
|---|---|---|---|---|
| Mean | 24.4 ± 3.21 | 24.1 ± 2.81 | 24.3 ± 2.99 | 24.3 ± 3.00 |
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