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Performance of the Travoprost Intraocular Implant
Phase 2 trial testing Travoprost Intracameral Implant exchanged at Month 12 in Glaucoma, Open-Angle in 210 participants. Completed in 2 November 2023.
| Lead sponsor | Glaukos Corporation |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 210 |
| Start date | 10 March 2021 |
| Primary completion | 2 November 2023 |
| Estimated completion | 2 November 2023 |
| Sites | 1 location across Armenia |
Glaukos Corporation — full company profile →
18 and older, any sex, with Glaucoma, Open-Angle or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 (12-month Exchange) | 5.57 | ± 3.02 |
concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS
| Group | Value | 95% CI |
|---|---|---|
| Cohort 2 (3-month Exchange) | 4.98 | ± 2.50 |
concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS
| Group | Value | 95% CI |
|---|---|---|
| Cohort 3 (6-month Exchange) | 3.74 | ± 2.22 |
concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS
| Group | Value | 95% CI |
|---|---|---|
| Cohort 4 (24-month Exchange) | 3.35 | ± 1.51 |
concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS
| Group | Value | 95% CI |
|---|---|---|
| Cohort 5 (21-month Exchange) | 3.80 | ± 1.58 |
concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS
| Group | Value | 95% CI |
|---|---|---|
| Cohort 6 (18-month Exchange) | 2.22 | ± 1.24 |
concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS
| Group | Value | 95% CI |
|---|---|---|
| Cohort 7 15-month Exchange) | 2.03 | ± 0.736 |
percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 (12-month Exchange) | 50.2 | ± 6.58 |
percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC
| Group | Value | 95% CI |
|---|---|---|
| Cohort 2 (3-month Exchange) | 78.8 | ± 3.15 |
percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC
| Group | Value | 95% CI |
|---|---|---|
| Cohort 3 (6-month Exchange) | 69.8 | ± 8.51 |
percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC
| Group | Value | 95% CI |
|---|---|---|
| Cohort 4 (24-month Exchange) | 16.3 | ± 7.88 |
percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC
| Group | Value | 95% CI |
|---|---|---|
| Cohort 5 (21-month Exchange) | 28.0 | ± 5.76 |
Time frame: initial travoprost intracameral implant period plus 4 weeks post-exchange. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 (12-month Exchange) | Cohort 2 (3-month Exchange) | Cohort 3 (6-month Exchange) | Cohort 4 (24-month Exchange) | Cohort 5 (21-month Exchange) | Cohort 6 (18-month Exchange) | Cohort 7 (15-month Exchange) |
|---|---|---|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | — | — | — | — | — | — | — |
| Reaction | System | Cohort 1 (12-month Exchange) | Cohort 2 (3-month Exchange) | Cohort 3 (6-month Exchange) | Cohort 4 (24-month Exchange) | Cohort 5 (21-month Exchange) | Cohort 6 (18-month Exchange) | Cohort 7 (15-month Exchange) |
|---|---|---|---|---|---|---|---|---|
| Corona virus infection | Infections and infestations | — | — | — | — | — | — | — |
| Intraocular pressure increased | Investigations | — | — | — | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — | — | — |
| Iridodialysis | Eye disorders | — | — | — | — | — | — | — |
| Hyphaema | Injury, poisoning and procedural complications | — | — | — | — | — | — | — |
Most-reported serious reactions: Myocardial infarction.
Data from ClinicalTrials.gov NCT06582732 adverse events section.
To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months
1 peer-reviewed publication reference this trial (live from Europe PMC):
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